Trial · NCT01321723

Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women

NCT01321723, Phase 2, Completed, Unigene Laboratories Inc.; results first posted 2013-02-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women. Trials, record NCT01321723. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01321723

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Trial

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

Title: Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women
NCT number: NCT01321723
Status: Completed
Phases: Phase 2
Enrollment: 97 participants, actual
Lead sponsor: Unigene Laboratories Inc.
Conditions: Postmenopausal Osteoporosis
Interventions: PTH analog, Placebo, Forsteo (Teriparatide)
First posted: 2011-03-23
Last updated: 2013-03-01
Results first posted: 2013-02-21

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24	24 weeks from baseline
Secondary	% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24	24 weeks from baseline	Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used.
Secondary	Systemic Absorption of PTH at Week 24	24 weeks	AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)
Secondary	% Change From Baseline in Bone Formation Marker (P1NP) at Week 24	24 weeks from baseline

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24	24 weeks from baseline	mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.	percentage of change	MEAN
POST_HOC	Number of Participants With AEs as a Measure of Safety and Tolerability	24 weeks	Overall Summary of Adverse Events - Each subject with an event is counted only once although they may have several events.	participants	NUMBER
SECONDARY	% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24	24 weeks from baseline	mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.	percentage of change	MEAN
SECONDARY	Systemic Absorption of PTH at Week 24	24 weeks		pg* hr/mL	MEAN
SECONDARY	% Change From Baseline in Bone Formation Marker (P1NP) at Week 24	24 weeks from baseline	mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.	percentage of change	MEAN

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Value	Spread	Units
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24	Forsteo (Teriparatide)	5.07	Standard Deviation 3.543	percentage of change
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24	PTH Analog Tablets	2.21	Standard Deviation 2.503	percentage of change
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24	Placebo	-0.17	Standard Deviation 2.739	percentage of change
Number of Participants With AEs as a Measure of Safety and Tolerability	Forsteo (Teriparatide)	23		participants
Number of Participants With AEs as a Measure of Safety and Tolerability	PTH Analog Tablets	30		participants
Number of Participants With AEs as a Measure of Safety and Tolerability	Placebo	21		participants
% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24	Forsteo (Teriparatide)	113.32	Standard Deviation 102.932	percentage of change
% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24	PTH Analog Tablets	12.72	Standard Deviation 36.547	percentage of change
% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24	Placebo	15.13	Standard Deviation 23.940	percentage of change
Systemic Absorption of PTH at Week 24	Forsteo (Teriparatide)	152	Standard Deviation 65.7	pg* hr/mL

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Forsteo (Teriparatide)	32
Overall Study	STARTED	PTH Analog Tablets	33
Overall Study	STARTED	Placebo	32
Overall Study	COMPLETED	Forsteo (Teriparatide)	27
Overall Study	COMPLETED	PTH Analog Tablets	28
Overall Study	COMPLETED	Placebo	28
Overall Study	NOT COMPLETED	Forsteo (Teriparatide)	5
Overall Study	NOT COMPLETED	PTH Analog Tablets	5
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events84

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	Forsteo (Teriparatide)	2	32	2
other	Abdominal pain	Gastrointestinal disorders	PTH Analog Tablets	6	33	6
other	Abdominal pain	Gastrointestinal disorders	Placebo	2	32	2
other	Abdominal pain upper	Gastrointestinal disorders	Forsteo (Teriparatide)	0	32	0
other	Abdominal pain upper	Gastrointestinal disorders	PTH Analog Tablets	13	33	13
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	6	32	6
other	Arthralgia	Musculoskeletal and connective tissue disorders	Forsteo (Teriparatide)	1	32	1
other	Arthralgia	Musculoskeletal and connective tissue disorders	PTH Analog Tablets	0	33	0
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	2	32	2
other	Back pain	Musculoskeletal and connective tissue disorders	Forsteo (Teriparatide)	3	32	3

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Forsteo (Teriparatide)
Total, all-cause mortality	PTH Analog Tablets
Total, all-cause mortality	Placebo
Total, other adverse events	Forsteo (Teriparatide)	23	32
Total, other adverse events	PTH Analog Tablets	30	33
Total, other adverse events	Placebo	21	32
Total, serious adverse events	Forsteo (Teriparatide)	1	32
Total, serious adverse events	PTH Analog Tablets	2	33
Total, serious adverse events	Placebo	2	32

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23234813	RESULT	PubMed
23719683	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 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/NCT01321723

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