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CompletedNCT01321723Updated Mar 1, 2013Results posted

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

A Phase 2 interventional study of PTH analog and Placebo in Postmenopausal Osteoporosis, sponsored by Unigene Laboratories Inc.. Completed at 4 sites in 2 countries. Open to female participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-03-01.

Sponsored by Unigene Laboratories Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
97
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
Female
01

Study summary

This study is designed to provide information about the bone anabolic properties and absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of 24 weeks to postmenopausal women with osteoporosis.

Read the detailed description

The choice of a 24-week treatment period was based on published studies of PTH which demonstrate its potential to produce a statistically significant increase in BMD in patients with postmenopausal osteoporosis within that observation period.

02

Conditions studied

  • Postmenopausal Osteoporosis

Keywords

  • Osteoporosis
  • Bone Diseases, Metabolic
  • Bone Diseases
  • Bone Density Conservation Agents
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 97 is close to the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

This is the only study on the registry with Unigene Laboratories Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Healthy postmenopausal women (45-80 years old) with a diagnosis of osteoporosis

Exclusion criteria

Exclusion Criteria:

  • Use of estrogen or hormone replacement therapy
  • Use of bisphosphonates, strontium ranelate or denosumab
  • Use of parathyroid analogues or other bone metabolic agents
  • Medical conditions which might alter bone metabolism
  • Any known clinically significant disease affecting calcium metabolism or history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia
  • Impairment of thyroid function
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
97 participants (actual)

Study arms

  • Experimental
    PTH analog tablet

    PTH(1-31) 5 mg tablet, once daily

    Drug: PTH analog

  • Placebo comparator
    Placebo

    Placebo matching tablet, once daily

    Drug: Placebo

  • Active comparator
    Forsteo

    Forsteo (teriparatide) 20 mcg SC Injection, once daily

    Drug: Forsteo (Teriparatide)

Interventions

  • DrugPTH analog

    A recombinant 1-31 amino acid fragment of PTH.

    Also known as: PTH(1-31)

  • DrugPlacebo
  • DrugForsteo (Teriparatide)

    A recombinant 1-34 amino acid fragment of PTH.

    Also known as: Forteo (US)

06

What researchers measure

Primary outcomes

  1. % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24

    Time frame: 24 weeks from baseline

Secondary outcomes

  1. % Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24

    Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used.

    Time frame: 24 weeks from baseline

  2. Systemic Absorption of PTH at Week 24

    AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)

    Time frame: 24 weeks

  3. % Change From Baseline in Bone Formation Marker (P1NP) at Week 24

    Time frame: 24 weeks from baseline

07

Results

Posted Feb 21, 2013

Participant flow

Participant flow — Overall Study
MilestoneForsteo (Teriparatide)PTH Analog TabletsPlacebo
Started323332
Completed272828
Not completed554
Withdrew: Adverse event352
Withdrew: Withdrawal by subject202

Outcome measures

Primary% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24
Time frame:
24 weeks from baseline
Reported as:
Mean · percentage of change
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24
percentage of changeForsteo (Teriparatide)PTH Analog TabletsPlacebo
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 245.07 ± 3.5432.21 ± 2.503-0.17 ± 2.739
Post-hocNumber of Participants With AEs as a Measure of Safety and Tolerability
Time frame:
24 weeks
Reported as:
Number · participants
Number of Participants With AEs as a Measure of Safety and Tolerability
participantsForsteo (Teriparatide)PTH Analog TabletsPlacebo
Number of Participants With AEs as a Measure of Safety and Tolerability233021
Secondary% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24

Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used.

Time frame:
24 weeks from baseline
Reported as:
Mean · percentage of change
% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24
percentage of changeForsteo (Teriparatide)PTH Analog TabletsPlacebo
% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24113.32 ± 102.93212.72 ± 36.54715.13 ± 23.940
SecondarySystemic Absorption of PTH at Week 24

AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)

Time frame:
24 weeks
Reported as:
Mean · pg* hr/mL
Systemic Absorption of PTH at Week 24
pg* hr/mLForsteo (Teriparatide)PTH Analog Tablets
Systemic Absorption of PTH at Week 24152 ± 65.7165 ± 180
Secondary% Change From Baseline in Bone Formation Marker (P1NP) at Week 24
Time frame:
24 weeks from baseline
Reported as:
Mean · percentage of change
% Change From Baseline in Bone Formation Marker (P1NP) at Week 24
percentage of changeForsteo (Teriparatide)PTH Analog TabletsPlacebo
% Change From Baseline in Bone Formation Marker (P1NP) at Week 24210.07 ± 202.61312.05 ± 37.055-1.75 ± 27.459

Adverse events

Collected over All AEs were recorded in the CRF during the course of the study. Serious adverse events (SAEs) were reported to the Sponsor within 24 hours of awareness.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Forsteo (Teriparatide)—1/32 (3.1%)23/32 (71.9%)
PTH Analog Tablets—2/33 (6.1%)30/33 (90.9%)
Placebo—2/32 (6.3%)21/32 (65.6%)
Most frequent serious events
Most frequent serious events
EventForsteo (Teriparatide)PTH Analog TabletsPlacebo
Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/320/330/32
HeadacheNervous system disorders0/320/331/32
Ovarian cystReproductive system and breast disorders0/320/331/32
Atrial flutterCardiac disorders0/321/330/32
Wrist fractureInjury, poisoning and procedural complications0/321/330/32
Most frequent other events
Showing 10 of 23
Most frequent other events
EventForsteo (Teriparatide)PTH Analog TabletsPlacebo
Abdominal pain upperGastrointestinal disorders0/3213/336/32
Abdominal painGastrointestinal disorders2/326/332/32
NauseaGastrointestinal disorders3/325/332/32
HeadacheNervous system disorders4/323/332/32
HypotensionVascular disorders0/324/330/32
SyncopeCardiac disorders0/324/330/32
Back painMusculoskeletal and connective tissue disorders3/322/331/32
DizzinessVascular disorders3/323/332/32
NasopharyngitisInfections and infestations3/323/333/32
Pain in extremityMusculoskeletal and connective tissue disorders3/320/332/32

Baseline characteristics

Age Continuous
Age Continuous(years)Forsteo (Teriparatide)PTH Analog TabletsPlaceboTotal
Mean66.5 ± 6.9967.4 ± 3.9566.1 ± 6.0966.7 ± 5.77
Sex: Female, Male
Sex: Female, Male(Participants)Forsteo (Teriparatide)PTH Analog TabletsPlaceboTotal
Female32333297
Male0000
08

Study locations

4 sites
  • CCBR
    Aalborg, Denmark
  • CCBR
    Ballerup, Denmark
  • CCBR
    Vejle, Denmark
  • CCBR
    Tallinn, Estonia
09

References and documents

Publications

  • Henriksen K, Andersen JR, Riis BJ, Mehta N, Tavakkol R, Alexandersen P, Byrjalsen I, Valter I, Nedergaard BS, Teglbjaerg CS, Stern W, Sturmer A, Mitta S, Nino AJ, Fitzpatrick LA, Christiansen C, Karsdal MA. Evaluation of the efficacy, safety and pharmacokinetic profile of oral recombinant human parathyroid hormone [rhPTH(1-31)NH(2)] in postmenopausal women with osteoporosis. Bone. 2013 Mar;53(1):160-6. doi: 10.1016/j.bone.2012.11.045. Epub 2012 Dec 9. PubMed 23234813 ↗
  • Sturmer A, Mehta N, Giacchi J, Cagatay T, Tavakkol R, Mitta S, Fitzpatrick L, Wald J, Trang J, Stern W. Pharmacokinetics of oral recombinant human parathyroid hormone [rhPTH(1-31)NH(2)] in postmenopausal women with osteoporosis. Clin Pharmacokinet. 2013 Nov;52(11):995-1004. doi: 10.1007/s40262-013-0083-4. PubMed 23719683 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01321723
Lead sponsor
Unigene Laboratories Inc.
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Mar 23, 2011
Start date
Feb 2011
Primary completion
Oct 2011
Completion
Oct 2011
Results posted
Feb 21, 2013
Last update
Mar 1, 2013

Study contacts

Christence S Teglbjaerg, MD
principal investigator · CCBR
Bettina S Nedergaard, MD
principal investigator · CCBR
Peter Alexandersen, MD
principal investigator · CCBR
Ivo Valter, MD
principal investigator · CCBR

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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