Osteoporosis
Conditions
Keywords
disease-related problem/condition, osteoporosis, rare disease
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
Interventions
DRUGhuman parathyroid hormone
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
29 Years to 67 Years
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed