Trial · NCT00525798

A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

NCT00525798, Phase 3, Completed, Nordic Bioscience A/S; results first posted 2012-10-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D. Trials, record NCT00525798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00525798

On this page

Trial

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

Title: A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
NCT number: NCT00525798
Status: Completed
Phases: Phase 3
Enrollment: 4,665 participants, actual
Lead sponsor: Nordic Bioscience A/S
Conditions: Osteoporosis
Interventions: SMC021 Oral calcitonin, SMC021 Placebo
First posted: 2007-09-06
Last updated: 2012-10-29
Results first posted: 2012-10-18

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Number of Patients With New Vertebral Fractures	From baseline to month 36	The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter). The outcome is the number of new vertebral fractures from baseline to 36 months.
Secondary	Number of Patients With Non-vertebral Fractures	From baseline to month 36	The secondary outcome was the occurrence or not of a non-vertebral fracture during the 3 year observation period. Non-vertebral fractures of interest were: hip fractures, forearm fractures, humurus fractures, rib fractures and clavicular fractures. Any new non-vertebral fractures while on-study were recorded. A copy of radiographs confirming the fracture, as well as a copy of the radiologist's report was to be obtained. A copy of the emergency room discharge letter or a hospital discharge letter was also obtained.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients With New Vertebral Fractures	From baseline to month 36	all patients randomized who received at least one dose of study drug, with the addition of evaluable baseline spine X-ray and at least one follow-up for calculation of vertebral fractures.	Participants	NUMBER
SECONDARY	Number of Patients With Non-vertebral Fractures	From baseline to month 36	all randomized patients	Participants	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Number of Patients With New Vertebral Fractures	SMC021	94	Participants
Number of Patients With New Vertebral Fractures	Placebo	99	Participants
Number of Patients With Non-vertebral Fractures	SMC021	75	Participants
Number of Patients With Non-vertebral Fractures	Placebo	82	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	SMC021	2,334
Overall Study	STARTED	Placebo	2,331
Overall Study	COMPLETED	SMC021	1,578
Overall Study	COMPLETED	Placebo	1,732
Overall Study	NOT COMPLETED	SMC021	756
Overall Study	NOT COMPLETED	Placebo	599

Source ClinicalTrials.gov

Adverse events862

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
other	Nausea	Gastrointestinal disorders	SMC021	357	2,334
other	Nausea	Gastrointestinal disorders	Placebo	117	2,331
other	Back Pain	Musculoskeletal and connective tissue disorders	SMC021	311	2,334
other	Back Pain	Musculoskeletal and connective tissue disorders	Placebo	339	2,331
other	Arthralgia	Musculoskeletal and connective tissue disorders	SMC021	284	2,334
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	320	2,331
other	Hot flush	Vascular disorders	SMC021	263	2,334
other	Hot flush	Vascular disorders	Placebo	41	2,331
other	Nasopharyngitis	Infections and infestations	SMC021	262	2,334
other	Nasopharyngitis	Infections and infestations	Placebo	269	2,331

1 to 10 of 862Source ClinicalTrials.gov

See all 862 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SMC021
Total, all-cause mortality	Placebo
Total, other adverse events	SMC021	2,152	2,334
Total, other adverse events	Placebo	2,141	2,331
Total, serious adverse events	SMC021	340	2,334
Total, serious adverse events	Placebo	378	2,331

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20932224	DERIVED

Source 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 comparisons3

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

Comparison	Source
SMC021 vs Placebo: Number of Patients With New Vertebral Fractures	Trial comparisons
SMC021 vs Placebo: Number of Patients With Non-vertebral Fractures	Trial comparisons
SMC021 vs Placebo: serious adverse events	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.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license 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/NCT00525798

GET https://conductscience.org/api/trials/v1/NCT00525798/events?page=2

API reference For AI assistants