Trial · NCT00959764

A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women

NCT00959764, Phase 3, Completed, Tarsa Therapeutics, Inc.; results first posted 2013-11-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women. Trials, record NCT00959764. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00959764

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Trial

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

Title: A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women
NCT number: NCT00959764
Status: Completed
Phases: Phase 3
Enrollment: 565 participants, actual
Lead sponsor: Tarsa Therapeutics, Inc.
Conditions: Osteoporosis, Postmenopausal
Interventions: Oral Calcitonin Tablets, Intranasal Calcitonin, Placebo tablets and placebo intranasal spray
First posted: 2009-08-17
Last updated: 2013-11-19
Other registries' IDs: eudract:2008-003322-42
Results first posted: 2013-11-19

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine	48 weeks	Bone Mineral Density is measured by Dual-Energy X-ray Absorptiometry (DXA) body scans. Two scans were taken for each timepoint(baseline, week 24 and week 48) and the mean of the two values was entered. The primary outcome timepoint was 48 weeks, but if a patient did not complete the full study, then the 24 week BMD value was used as Last Observation Carried Forward. The percentage change from the baseline value, set as 0%, was recorded as the primary outcome measure.
Secondary	Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)	24 weeks	Change from baseline in plasma CTx-1 at 24 and 48 weeks. CTx-1 is an accepted plasma biomarker as evidence of an effect on bone resorption and the effect of oral calcitonin was compared to that of intranasal calcitonin, both vs placebo.
Secondary	Change in Plasma CTx-1 From Baseline	48 weeks	Percent change from baseline of plasma CTx-1 at end of study=48 weeks

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine	48 weeks	Patients who were randomized, received treatment, and had at least one post-baseline BMD value measured at least 154 days after randomization.	Percentage increase from baseline	LEAST_SQUARES_MEAN
SECONDARY	Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)	24 weeks	Modified Intent-to-Treat Population	percentage change from baseline	LEAST_SQUARES_MEAN
SECONDARY	Change in Plasma CTx-1 From Baseline	48 weeks	Modified Intent-to-Treat Population	Percentage change from baseline	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Value	Spread	Units
Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine	Oral Calcitonin	1.53	Standard Deviation 3.17	Percentage increase from baseline
Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine	Nasal Calcitonin	0.76	Standard Deviation 2.91	Percentage increase from baseline
Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine	Placebo	0.47	Standard Deviation 3.21	Percentage increase from baseline
Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)	Oral Calcitonin	-42.93	Standard Deviation 41.99	percentage change from baseline
Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)	Nasal Calcitonin	-24.64	Standard Deviation 41.61	percentage change from baseline
Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)	Placebo	-21.09	Standard Deviation 62.46	percentage change from baseline
Change in Plasma CTx-1 From Baseline	Oral Calcitonin	-29.92	Standard Deviation 47.53	Percentage change from baseline
Change in Plasma CTx-1 From Baseline	Nasal Calcitonin	-11.41	Standard Deviation 40.24	Percentage change from baseline
Change in Plasma CTx-1 From Baseline	Placebo	-11.83	Standard Deviation 35.58	Percentage change from baseline

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Oral Calcitonin	271
Overall Study	STARTED	Nasal Calcitonin	185
Overall Study	STARTED	Placebo	109
Overall Study	COMPLETED	Oral Calcitonin	176
Overall Study	COMPLETED	Nasal Calcitonin	128
Overall Study	COMPLETED	Placebo	73
Overall Study	NOT COMPLETED	Oral Calcitonin	95
Overall Study	NOT COMPLETED	Nasal Calcitonin	57
Overall Study	NOT COMPLETED	Placebo	36

Source ClinicalTrials.gov

Adverse events153

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	abdominal pain	Gastrointestinal disorders	Oral Calcitonin	44	263	65
other	abdominal pain	Gastrointestinal disorders	Nasal Calcitonin	29	182	51
other	abdominal pain	Gastrointestinal disorders	Placebo	15	104	23
other	abdominal pain upper	Gastrointestinal disorders	Oral Calcitonin	29	263	39
other	abdominal pain upper	Gastrointestinal disorders	Nasal Calcitonin	18	182	28
other	abdominal pain upper	Gastrointestinal disorders	Placebo	9	104	13
other	nausea	Gastrointestinal disorders	Oral Calcitonin	32	263	40
other	nausea	Gastrointestinal disorders	Nasal Calcitonin	15	182	18
other	nausea	Gastrointestinal disorders	Placebo	7	104	11
other	constipation	Gastrointestinal disorders	Oral Calcitonin	18	263	20

1 to 10 of 153Source ClinicalTrials.gov

See all 153 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oral Calcitonin
Total, all-cause mortality	Nasal Calcitonin
Total, all-cause mortality	Placebo
Total, other adverse events	Oral Calcitonin	44	263
Total, other adverse events	Nasal Calcitonin	146	182
Total, other adverse events	Placebo	83	104
Total, serious adverse events	Oral Calcitonin	20	263
Total, serious adverse events	Nasal Calcitonin	9	182
Total, serious adverse events	Placebo	9	104

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22437792	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/NCT00959764

GET https://conductscience.org/api/trials/v1/NCT00959764/events?page=2

API reference For AI assistants