Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis
human parathyroid hormone
Bone Diseases+7
+ Bone Diseases, Metabolic
+ Metabolic Diseases
Treatment Study
Summary
Study start date: October 1, 1999
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 29 to 67 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Columbia University College of Physicians and Surgeons
New York, United StatesOpen Columbia University College of Physicians and Surgeons in Google Maps