NCT01321723

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_2

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 21, 2013

Completed
Last Updated

March 1, 2013

Status Verified

January 1, 2013

Enrollment Period

8 months

First QC Date

March 16, 2011

Results QC Date

December 12, 2012

Last Update Submit

February 21, 2013

Conditions

Postmenopausal Osteoporosis

Keywords

OsteoporosisBone Diseases, MetabolicBone DiseasesBone Density Conservation Agents

Outcome Measures

Primary Outcomes (1)

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

    24 weeks from baseline

Secondary Outcomes (3)

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

    24 weeks from baseline

  • Systemic Absorption of PTH at Week 24

    24 weeks

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

    24 weeks from baseline

Study Arms (3)

PTH analog tablet

EXPERIMENTAL

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

Drug: PTH analog

Placebo

PLACEBO COMPARATOR

Placebo matching tablet, once daily

Drug: Placebo

Forsteo

ACTIVE COMPARATOR

Forsteo (teriparatide) 20 mcg SC Injection, once daily

Drug: Forsteo (Teriparatide)

Interventions

PTH analogDRUG

A recombinant 1-31 amino acid fragment of PTH.

Also known as: PTH(1-31)
PTH analog tablet
PlaceboDRUG
Placebo
Forsteo (Teriparatide)DRUG

A recombinant 1-34 amino acid fragment of PTH.

Also known as: Forteo (US)
Forsteo

Eligibility Criteria

Age45 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CCBR

Aalborg, Denmark

Location

CCBR

Ballerup Municipality, Denmark

Location

CCBR

Vejle, Denmark

Location

CCBR

Tallinn, Estonia

Location

Related Publications (2)

  • 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.

    PMID: 23234813RESULT

  • 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.

    PMID: 23719683DERIVED

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosisBone Diseases, MetabolicBone Diseases

Interventions

parathyroid hormone (1-31)Teriparatide

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Nozer Mehta, PhD. Chief Scientific Officer
Organization
Unigene Laboratories, Inc.
nmehta@unigene.com
(973) 265-1100

Study Officials

  • Christence S Teglbjaerg, MD

    CCBR

    PRINCIPAL INVESTIGATOR

  • Bettina S Nedergaard, MD

    CCBR

    PRINCIPAL INVESTIGATOR

  • Peter Alexandersen, MD

    CCBR

    PRINCIPAL INVESTIGATOR

  • Ivo Valter, MD

    CCBR

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 23, 2011

Study Start

February 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

March 1, 2013

Results First Posted

February 21, 2013

Record last verified: 2013-01

Locations

ES(1)DK(3)