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Completed

NCT Number: NCT01224717

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

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.

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Key information

Conditions

Post-Menopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

45 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PTH134

Drug

Placebo

Drug

Forsteo

Drug

Primary outcomes

  1. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. Change from baseline in serum calcium levels after 12 weeks of treatment

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
First posted
Oct 20, 2010
Registry last updated
May 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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