Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women

Post-menopausal Osteoporosis Clinical Trial

Official title:

A Phase I, Partially Blinded, Randomized, Placebo Controlled, Active Comparator Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Post-menopausal Women After Daily Oral Doses of PTH134

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224717
• Other study ID #: CPTH134A2102
• Secondary ID: 2009-015933-64
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2010
• Last updated: May 12, 2011
• Start date: September 2010

Study information

• Verified date: May 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old

Exclusion Criteria:

• Use of estrogen or hormone replacement therapy

• Use of parathormone or parathormone fragments, calcitonin, aluminum supplements, within 12 months prior to first dose.

• Use of bisphosphonates and strontium ranelate

• Cancer or history of malignancy of any organ system

• Any radiation therapy to the skeleton.

• Any known clinically significant disease affecting calcium metabolism. Any history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia.

• History or clinical evidence of any impairment of thyroid function

• Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Post-menopausal Osteoporosis

Intervention

Drug:
• PTH134

• Placebo

• Forsteo

Locations

Country	Name	City	State
Denmark	Novartis Investigative Site	Aalborg
Denmark	Novartis Investigative Site	Ballerup
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Denmark,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: Effects of treatment on bone biomarkers. Measure levels of PINP, CTX-1, and serum calcium levels, serum phosphate, P1CP, bone-specific alkaline phosphatase, osteocalcin.		12 weeks	No
Secondary	Change from baseline in serum calcium levels after 12 weeks of treatment		12 weeks	Yes