Trial · NCT01611571

Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis

NCT01611571, Phase 3, Completed, Columbia University; results first posted 2014-03-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis. Trials, record NCT01611571. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01611571

On this page

Trial

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

Title: Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis
NCT number: NCT01611571
Status: Completed
Phases: Phase 3
Enrollment: 31 participants, actual
Lead sponsor: Columbia University
Conditions: Osteoporosis
Interventions: Risedronate, Teriparatide, Placebo Teriparatide, placebo Risedronate
First posted: 2012-06-05
Last updated: 2014-03-04
Results first posted: 2014-03-04

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Change in Spine Bone Density	18 months	change in spine bone density at 18 months measured by DXA 18 and 24 months
Secondary	Change in Hip Bone Density	baseline and 18 months	change in hip bone density measured by DXA
Secondary	Change in Forearm Bone Density	baseline and 18 months	change in 1/3 radius of forearm bone density as measured by DXA
Secondary	New Morphometric Vertebral Fractures	baseline through 18 months	counting the total new morphometric vertebral fractures as determined by x-ray from baseline through end of study
Secondary	Change in FN BMD at 18 Months	18 months	Change in the Femoral Neck BMD at 18 month

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Spine Bone Density	18 months	% change in LS BMD	LEAST_SQUARES_MEAN
SECONDARY	Change in Hip Bone Density	baseline and 18 months	% change in TH BMD	MEAN
SECONDARY	Change in Forearm Bone Density	baseline and 18 months	% change in 1/3 Radius BMD	MEAN
SECONDARY	New Morphometric Vertebral Fractures	baseline through 18 months	vertebral fracture	NUMBER
SECONDARY	Change in FN BMD at 18 Months	18 months	% change in TH BMD	MEAN

Source ClinicalTrials.gov

Results by group15

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

Outcome	Group	Value	Spread	Units
Change in Spine Bone Density	Active Risedronate Active Teriparatide	6.95	Standard Deviation 1.9	% change in LS BMD
Change in Spine Bone Density	Active Risedronte Placebo Teriparatide	3.76	Standard Deviation 1.8	% change in LS BMD
Change in Spine Bone Density	Placebo Risedronate Active Teriparatide	5.68	Standard Deviation 1.9	% change in LS BMD
Change in Hip Bone Density	Active Risedronate Active Teriparatide	3.86	Standard Deviation 1.1	% change in TH BMD
Change in Hip Bone Density	Active Risedronte Placebo Teriparatide	0.82	Standard Deviation 0.95	% change in TH BMD
Change in Hip Bone Density	Placebo Risedronate Active Teriparatide	0.29	Standard Deviation 0.95	% change in TH BMD
Change in Forearm Bone Density	Active Risedronate Active Teriparatide	1.6	Standard Deviation 0.6	% change in 1/3 Radius BMD
Change in Forearm Bone Density	Active Risedronte Placebo Teriparatide	0.11	Standard Deviation 0.77	% change in 1/3 Radius BMD
Change in Forearm Bone Density	Placebo Risedronate Active Teriparatide	0.02	Standard Deviation 0.77	% change in 1/3 Radius BMD
New Morphometric Vertebral Fractures	Active Risedronate Active Teriparatide	1		vertebral fracture

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Active Risedronate + Active Teriparatide	11
Overall Study	STARTED	Active Risedronte + Placebo Teriparatide	10
Overall Study	STARTED	Placebo Risedronate + Active Teriparatide, Active Risedronate	10
Overall Study	COMPLETED	Active Risedronate + Active Teriparatide	10
Overall Study	COMPLETED	Active Risedronte + Placebo Teriparatide	10
Overall Study	COMPLETED	Placebo Risedronate + Active Teriparatide, Active Risedronate	9
Overall Study	NOT COMPLETED	Active Risedronate + Active Teriparatide	1
Overall Study	NOT COMPLETED	Active Risedronte + Placebo Teriparatide	0
Overall Study	NOT COMPLETED	Placebo Risedronate + Active Teriparatide, Active Risedronate	1

Source ClinicalTrials.gov

Adverse events24

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	Fracture, patella	Injury, poisoning and procedural complications	Active Risedronate Active Teriparatide	1	10	1
other	Fracture, patella	Injury, poisoning and procedural complications	Active Risedronte Placebo Teriparatide	0	10	0
other	Fracture, patella	Injury, poisoning and procedural complications	Placebo Risedronate Active Teriparatide, Active Risedronate	0	9	0
other	Fracture, vertebral	Endocrine disorders	Active Risedronate Active Teriparatide	1	10	1
other	Fracture, vertebral	Endocrine disorders	Active Risedronte Placebo Teriparatide	1	10	1
other	Fracture, vertebral	Endocrine disorders	Placebo Risedronate Active Teriparatide, Active Risedronate	0	9	0
other	Fatigue	Endocrine disorders	Active Risedronate Active Teriparatide	0	10	0
other	Fatigue	Endocrine disorders	Active Risedronte Placebo Teriparatide	1	10	1
other	Fatigue	Endocrine disorders	Placebo Risedronate Active Teriparatide, Active Risedronate	0	9	0
other	Gastroesophageal Reflux	Gastrointestinal disorders	Active Risedronate Active Teriparatide	1	10	4

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active Risedronate Active Teriparatide
Total, all-cause mortality	Active Risedronte Placebo Teriparatide
Total, all-cause mortality	Placebo Risedronate Active Teriparatide, Active Risedronate
Total, other adverse events	Active Risedronate Active Teriparatide	6	10
Total, other adverse events	Active Risedronte Placebo Teriparatide	3	10
Total, other adverse events	Placebo Risedronate Active Teriparatide, Active Risedronate	2	9
Total, serious adverse events	Active Risedronate Active Teriparatide	0	10
Total, serious adverse events	Active Risedronte Placebo Teriparatide	0	10
Total, serious adverse events	Placebo Risedronate Active Teriparatide, Active Risedronate	0	9

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23099796	RESULT

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 comparisons0

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

None in this release.

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/NCT01611571

GET https://conductscience.org/api/trials/v1/NCT01611571/events?page=2

API reference For AI assistants