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Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT00004406
Collaborator
(none)
36
Enrollment
1
Location
57
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

OBJECTIVES:
  1. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.
Condition or Disease Intervention/Treatment Phase
  • Drug: human parathyroid hormone
 N/A

Detailed Description

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. All patients self-administer daily subcutaneous injections of human parathyroid hormone (1-34) or placebo for a period of 2.5 years.

Patients are followed regularly for unacceptable toxicities.

Completion date provided represents the completion date of the grant per OOPD records

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Treatment
Study Start Date :
Oct 1, 1999
Study Completion Date :
Jul 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    29 Years to 67 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    PROTOCOL ENTRY CRITERIA:

    --Disease Characteristics--

    Osteoporosis as defined by: Bone mineral density at the lumbar spine or femoral neck that is 2.5 standard deviations below peak bone mass reference value (T score less than -2.5)

    No family history of male osteoporosis

    No other metabolic bone disease

    --Prior/Concurrent Therapy--

    Endocrine therapy:

    • No concurrent glucocorticoid therapy

    • No prior steroid use

    Surgery: No prior gastrointestinal tract surgery

    Other: No prior or concurrent anticonvulsant therapy

    --Patient Characteristics--

    Hematopoietic: Normal CBC

    Hepatic: Normal liver function

    Renal: Normal renal function

    Other:

    • Normal thyroid function

    • Normal adrenal function

    • Normal gonadal status

    • No myeloma or other malignancy

    • No alcoholism, hypercortisolism or diabetes mellitus

    • No gastrointestinal tract disease or disorder associated with malabsorption

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University College of Physicians and Surgeons New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University

    Investigators

    • Study Chair: John Paul Bilezikian, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004406
    Other Study ID Numbers:
    • 199/13293
    • CPS-CU-FDR001024
    First Posted:
    Oct 19, 1999
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    Jan 1, 2000
    Keywords provided by , ,
    disease-related problem/condition
    osteoporosis
    rare disease
    Additional relevant MeSH terms:
    Osteoporosis
    Hormones
    Parathyroid Hormone

    Study Results

    No Results Posted as of Mar 25, 2015