search
Back to results

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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
human parathyroid hormone
Sponsored by
Columbia University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring disease-related problem/condition, osteoporosis, rare disease

Eligibility Criteria

29 Years - 67 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University College of Physicians and Surgeons

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 18, 1999
Last Updated
March 24, 2015
Sponsor
Columbia University
search

1. Study Identification

Unique Protocol Identification Number
NCT00004406
Brief Title
Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2000
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Columbia University

4. Oversight

5. Study Description

Brief Summary
OBJECTIVES: I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
disease-related problem/condition, osteoporosis, rare disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
human parathyroid hormone

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Paul Bilezikian
Organizational Affiliation
Columbia University
Official's Role
Study Chair
Facility Information:
Facility Name
Columbia University College of Physicians and Surgeons
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs