Trial · NCT00529373

A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)

NCT00529373, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2019-11-14

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018). Trials, record NCT00529373. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00529373

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)
NCT number: NCT00529373
Status: Terminated
Phases: Phase 3
Enrollment: 16,071 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Postmenopausal Osteoporosis
Interventions: Odanacatib, Placebo for Odanacatib, Vitamin D3, Calcium carbonate
First posted: 2007-09-14
Last updated: 2024-06-11
Other registries' IDs: eudract:2007-002693-66
Results first posted: 2019-11-14
Limitations and caveats: The study was terminated early due to an observed increase in risk of stroke in Protocol MK-0822-018.

Source ClinicalTrials.gov

Registered outcomes89

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Base Study: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture	Up to approximately 60 months of observation	Morphometric vertebral fractures were assessed by central adjudication on lumbar and thoracic spinal radiographs acquired at baseline and at Months 6, 12, and subsequent yearly time points. Incident fractures (i.e., occurring after baseline) in previously normal vertebral bodies and/or those occurring after baseline in previously fractured vertebral bodies (Genant semiquantitative \[SQ\] Grade 1-3) (T4 to L4) were confirmed by quantitative morphometric (QM) and either SQ or binary SQ (yes/no) methodologies. A time-to-event methodology was used to evaluate results: life-table estimates of the incidence proportion (cumulative incidence) of participants with at least one morphometric vertebral fracture were assessed at Months 6, 12, and subsequent yearly intervals; an interval-censored approach was then used to determine incidence rate (number of participants with a morphometric fracture per 100 person-years of follow-up).
Primary	Base Study: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated)	Up to approximately 60 months of observation	Osteoporotic clinical hip fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Hip fractures were fractures of the proximal femur confirmed as being located in the hip (i.e., sub-region not specified; cervical, and intertrochanteric). Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided.
Primary	Base Study: Time From Baseline to First Osteoporotic Clinical Non-Vertebral Fracture (Adjudicated)	Up to approximately 60 months of observation	Osteoporotic non-vertebral clinical fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Non-vertebral fractures were assessed across multiple anatomical sites including clavicle, distal femur or shaft, fibula, hip, humerus, pelvis, radius, ribs, sacrum, tibia, ulna, and wrist. Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided.
Primary	Base Study + First Extension: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture	Up to approximately 74 months of observation	Morphometric vertebral fractures were confirmed by central adjudication on lumbar and thoracic spinal radiographs acquired at baseline and at Months 6, 12, and subsequent yearly time points. Incident fractures (i.e., occurring after baseline) in previously normal vertebral bodies and/or those occurring after baseline in previously fractured vertebral bodies (Genant SQ Grade 1-3) (T4 to L4) were confirmed by QM and either SQ or binary SQ (yes/no) methodologies. A time-to-event methodology was used to evaluate results: life-table estimates of the incidence proportion (cumulative incidence) of participants with at least one morphometric vertebral fracture were assessed at Months 6, 12, and subsequent yearly intervals; an interval-censored approach was then used to determine incidence rate (number of participants with a morphometric fracture per 100 person-years of follow-up).
Primary	Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated)	Up to approximately 74 months of observation	Osteoporotic clinical hip fractures was confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Hip fractures were fractures of the proximal femur confirmed as being located in the hip (i.e., sub-region not specified; cervical, and intertrochanteric). Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided.
Primary	Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Non-Vertebral Fracture (Adjudicated)	Up to approximately 74 months of observation	Osteoporotic non-vertebral clinical fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Non-vertebral fractures were assessed across multiple anatomical sites including clavicle, distal femur and shaft, fibula, hip, humerus, pelvis, radius, ribs, sacrum, tibia, ulna, and wrist. Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided.
Primary	Base Study + First Extension: Rate of Adverse Events	Up to approximately 74 months of observation	An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The incidence rate of participants with adverse events (number of participants with an event per 100 person-years of follow-up) is provided.
Primary	Base Study + First Extension: Rate of Discontinuations From Study Treatment Due to an Adverse Event	Up to approximately 74 months of observation	An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The incidence rate of participant discontinuations from treatment due to adverse events (number of participants with an event per 100 person-years of follow-up) is provided.
Primary	Base Study + First Extension + Second Extension: Percent Change From Baseline in Bone Mineral Density (BMD) Measurements of the Total Hip	Baseline and once yearly, up to approximately 108 months of observation	BMD was measured by dual-energy x-ray absorptiometry (DXA) at the total hip starting at screening, and at yearly intervals until the end of the study (second extension study) for all participants who entered the second extension study. Least squares (LS) means percent change in BMD from original baseline are provided through Month 108 (Year 9). At Months 96 (Year 8) and 108 (Year 9), approximately 3% or fewer participants in each treatment group had BMD data, and results at those time points should be viewed with caution. NOTE: The mean percent change in BMD from baseline in participants originally randomized to placebo includes BMD results obtained after those participants were switched to open-label odanacatib, which occurred at different times relative to their start of blinded study medication in the base study.
Primary	Second Extension: Number of Participants Who Experienced an Adverse Event	Up to approximately 34 months of observation	An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

1 to 10 of 89Source ClinicalTrials.gov

See all 89 registered outcomes

Outcomes93

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Base Study: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture	Up to approximately 60 months of observation	The Full-Analysis-Set (FAS) including all randomized participants, who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study) with at least one spine radiograph on treatment (and at baseline) was used for analysis.	Parts. w/ fracture per 100 person-years	NUMBER
PRIMARY	Base Study: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated)	Up to approximately 60 months of observation	The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study) was used for analysis.	Parts. w/ fracture per 100 person-years	NUMBER
PRIMARY	Base Study: Time From Baseline to First Osteoporotic Clinical Non-Vertebral Fracture (Adjudicated)	Up to approximately 60 months of observation	The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study) was used for analysis.	Parts. w/ fracture per 100 person-years	NUMBER
PRIMARY	Base Study + First Extension: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture	Up to approximately 74 months of observation	The FAS including all randomized participants, who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study + first extension-double blind period \[dbp\]) with at least one spine radiograph on treatment (and at baseline) was used for analysis.	Parts. w/ fracture per 100 person-years	NUMBER
PRIMARY	Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated)	Up to approximately 74 months of observation	The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study + first extension-dbp) was used for analysis.	Parts. w/ fracture per 100 person-years	NUMBER
PRIMARY	Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Non-Vertebral Fracture (Adjudicated)	Up to approximately 74 months of observation	The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study + first extension-dbp) was used for analysis.	Parts. w/ fracture per 100 person-years	NUMBER
PRIMARY	Base Study + First Extension: Rate of Adverse Events	Up to approximately 74 months of observation	The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).	Parts. with event per 100 person-years	NUMBER
PRIMARY	Base Study + First Extension: Rate of Discontinuations From Study Treatment Due to an Adverse Event	Up to approximately 74 months of observation	The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).	Parts. with event per 100 person-years	NUMBER
PRIMARY	Base Study + First Extension + Second Extension: Percent Change From Baseline in Bone Mineral Density (BMD) Measurements of the Total Hip	Baseline and once yearly, up to approximately 108 months of observation	The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (total hip BMD) was used for analysis (base study + first extension-dbp + second extension).	Percent change	LEAST_SQUARES_MEAN
PRIMARY	Second Extension: Number of Participants Who Experienced an Adverse Event	Up to approximately 34 months of observation	The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for the analysis (second extension study).	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 93Source ClinicalTrials.gov

See all 93 outcomes

Results by group449

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Base Study: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture	Odanacatib 50 mg OW	1.27	Parts. w/ fracture per 100 person-years
Base Study: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture	Placebo	2.74	Parts. w/ fracture per 100 person-years
Base Study: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated)	Odanacatib 50 mg OW	0.28	Parts. w/ fracture per 100 person-years
Base Study: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated)	Placebo	0.54	Parts. w/ fracture per 100 person-years
Base Study: Time From Baseline to First Osteoporotic Clinical Non-Vertebral Fracture (Adjudicated)	Odanacatib 50 mg OW	1.85	Parts. w/ fracture per 100 person-years
Base Study: Time From Baseline to First Osteoporotic Clinical Non-Vertebral Fracture (Adjudicated)	Placebo	2.41	Parts. w/ fracture per 100 person-years
Base Study + First Extension: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture	Odanacatib 50 mg OW	1.33	Parts. w/ fracture per 100 person-years
Base Study + First Extension: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture	Placebo	2.74	Parts. w/ fracture per 100 person-years
Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated)	Odanacatib 50 mg OW	0.29	Parts. w/ fracture per 100 person-years
Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated)	Placebo	0.56	Parts. w/ fracture per 100 person-years

1 to 10 of 449Source ClinicalTrials.gov

See all 449 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Base Study	STARTED	Odanacatib 50 mg OW	8,043
Base Study	STARTED	Placebo	8,028
Base Study	COMPLETED	Odanacatib 50 mg OW	4,297
Base Study	COMPLETED	Placebo	3,960
Base Study	NOT COMPLETED	Odanacatib 50 mg OW	3,746
Base Study	NOT COMPLETED	Placebo	4,068
First Extension Study	STARTED	Odanacatib 50 mg OW	4,297
First Extension Study	STARTED	Placebo	3,960
First Extension Study	COMPLETED	Odanacatib 50 mg OW	3,144
First Extension Study	COMPLETED	Placebo	2,309

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events5,784

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Base Study + First Extension: Odanacatib 50 mg OW	477	8,043	552
other	Anaemia	Blood and lymphatic system disorders	Base Study + First Extension: Placebo	500	8,028	583
other	Anaemia	Blood and lymphatic system disorders	Second Extension: Odanacatib 50 mg OW	0	3,144	0
other	Anaemia	Blood and lymphatic system disorders	Second Extension: Odanacatib 50 mg OW (Placebo)	0	2,309	0
other	Cataract	Eye disorders	Base Study + First Extension: Odanacatib 50 mg OW	488	8,043	638
other	Cataract	Eye disorders	Base Study + First Extension: Placebo	492	8,028	652
other	Cataract	Eye disorders	Second Extension: Odanacatib 50 mg OW	0	3,144	0
other	Cataract	Eye disorders	Second Extension: Odanacatib 50 mg OW (Placebo)	0	2,309	0
other	Constipation	Gastrointestinal disorders	Base Study + First Extension: Odanacatib 50 mg OW	492	8,043	547
other	Constipation	Gastrointestinal disorders	Base Study + First Extension: Placebo	504	8,028	552

1 to 10 of 5,784Source ClinicalTrials.gov

See all 5,784 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Base Study + First Extension: Odanacatib 50 mg OW	378	8,043
Total, all-cause mortality	Base Study + First Extension: Placebo	327	8,028
Total, all-cause mortality	Second Extension: Odanacatib 50 mg OW	86	3,144
Total, all-cause mortality	Second Extension: Odanacatib 50 mg OW (Placebo)	39	2,309
Total, other adverse events	Base Study + First Extension: Odanacatib 50 mg OW	5,659	8,043
Total, other adverse events	Base Study + First Extension: Placebo	5,624	8,028
Total, other adverse events	Second Extension: Odanacatib 50 mg OW	311	3,144
Total, other adverse events	Second Extension: Odanacatib 50 mg OW (Placebo)	209	2,309
Total, serious adverse events	Base Study + First Extension: Odanacatib 50 mg OW	2,441	8,043
Total, serious adverse events	Base Study + First Extension: Placebo	2,446	8,028

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25432773	BACKGROUND	PubMed
31676222	DERIVED	PubMed
32119749	DERIVED	PubMed
33724542	DERIVED	PubMed
35711006	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Odanacatib 50 mg OW vs Placebo (Originally Assigned to Placebo): Second Extension: Number of Participants Who Experienced an Adverse Event	Trial comparisons
Odanacatib 50 mg OW vs Placebo (Originally Assigned to Placebo): Second Extension: Number of Participants Discontinuing Study Treatment Due to an Adverse Event	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00529373

GET https://conductscience.org/api/trials/v1/NCT00529373/registered?page=2

API reference For AI assistants