Clinical trial NCT01321723: Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women
Official title: A Double Blind, Randomized, Repeat Dose Parallel Group Study of Recombinant Human Parathyroid Hormone Analog Tablets, or Placebo Tablets, Compared to Open Label Forsteo® in Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postmenopausal Osteoporosis
Keywords: Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Bone Density Conservation Agents
Lead sponsor: Unigene Laboratories Inc.
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2011-03-23
Enrollment: 97
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24
timeFrame: 24 weeks from baseline
Secondary outcomes:
measure: % Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24
timeFrame: 24 weeks from baseline
measure: Systemic Absorption of PTH at Week 24
timeFrame: 24 weeks
measure: % Change From Baseline in Bone Formation Marker (P1NP) at Week 24
timeFrame: 24 weeks from baseline
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: CCBR
city: Ballerup
country: Denmark
facility: CCBR
city: Vejle
country: Denmark
facility: CCBR
city: Tallinn
country: Estonia
facility: CCBR
Study officials:
affiliation: CCBR
name: Christence S Teglbjaerg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CCBR
name: Bettina S Nedergaard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CCBR
name: Peter Alexandersen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CCBR
name: Ivo Valter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.