rhPTH Therapy for Low Turnover Bone Fragility

NCT00145886 | Terminated Phase 1

• 1 other identifier: 12901A
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how treatment with a new medication, recombinant human parathyroid hormone (rhPTH) affects calcium balance and bone strength.

Conditions

Osteopetrosis

Keywords

low bone turnover; sclerosing bone disorders,; osteopetrosis

Outcome Measures

Primary Outcomes (1)

• To describe the acute effects of rhPTH administration on calcium balance.

  The effects on calcium balance will be examined at the beginning, after 3 months, and after 12 months of treatment with rhPTH. The rational for examining calcium balance at these three time points is that (at least in patients wit osteoporosis treated with PTH) the initial response is primarily an increase in bone formation; at 3 months there is also a proportionate increase in bone resorption; and at 12 months there is an established general increase in bone turnover.

  The effects on calcium balance will be examined at the beginning, after 3 months, and after 12 months of treatment with rhPTH.

Secondary Outcomes (1)

• To examine the effect of 12 months of therapy with rhPTH on bone density, bone turnover and bone micro-architecture.

  Bone density will be measured at 0, 3, 6, and 12 months

Study Arms (1)

rhPTH

EXPERIMENTAL

Subjects will be treated rhPTH for 12 months

Drug: rhPTH

Interventions

rhPTH DRUG

Subjects will be treated with rhPTH for 12 months.

Also known as: Recombinant Human Parathyroid Hormone

rhPTH

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• :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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Osteopetrosis

Interventions

Parathyroid Hormone

Condition Hierarchy (Ancestors)

Osteosclerosis; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Tamara Vokes, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: February 1, 2003
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

US (1)