rhPTH Therapy for Low Turnover Bone Fragility

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2016
• Main ID: NCT00145886
• Date of registration: 01/09/2005
• Prospective Registration: No
• Primary sponsor: University of Chicago
• Public title: rhPTH Therapy for Low Turnover Bone Fragility
• Scientific title: Effect of 12 Months Treatment With rhPTH on Calcium Balance, Bone Turnover, Bone Mineral Density, and Bone Micro-architecture in Patients With Fractures Associated With Low Bone Turnover and Sclerosing Bone Disorders
• Date of first enrolment: February 2003
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00145886
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Tamara Vokes, MD
• Affiliation: University of Chicago

Key inclusion & exclusion criteria

Inclusion Criteria:

- :patients with history of increased bone fragility by BMD criteria (T score > -1). In
addition, the subjects will be enrolled only if they have clear evidence of low bone
turnover as indicated by low normal levels of biochemical markers of bone turnover
and finding of low bone turnover on bone biopsy. Each subject and his/her treating
physician will have agreed that the rhPTH is the best treatment for the patient.
Treatment with rhPTH will be considered only if the bone histomorphometry reveals a
low turnover state and excludes other known forms of bone disease such as
osteomalacia.

Exclusion Criteria:

- Subjects who are pregnant or younger than 20 will be excluded. Subjects cannot have
osteoporosis



Age minimum: 20 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Osteopetrosis

Intervention(s)

Drug: rhPTH

Primary Outcome(s)

To describe the acute effects of rhPTH administration on calcium balance. [Time Frame: The effects on calcium balance will be examined at the beginning, after 3 months, and after 12 months of treatment with rhPTH.]

Secondary Outcome(s)

To examine the effect of 12 months of therapy with rhPTH on bone density, bone turnover and bone micro-architecture. [Time Frame: Bone density will be measured at 0, 3, 6, and 12 months]

Secondary ID(s)

12901A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors