Can Parathyroid Hormone Injections Reverse Glucocorticoid-induced Osteoporosis
Status:
Completed
Trial end date:
2001-08-01
Target enrollment:
Participant gender:
Summary
Glucocorticoids are potent anti-inflammatory and immunosuppressive agents. However, prolonged
use of these potent agents results in severe bone loss and osteoporotic fractures.
Parathyroid hormone (1-34), when given as a daily injection has been found to dramatically
increase bone mass in osteoporotic animals and postmenopausal women. The purpose of this
study is to determine whether 2 years of daily PTH (1-34) injections will increase bone mass
and reduce the development of new fractures. In addition, we will follow the study subjects
for 2 more years to determine which type of anti-resorptive agent is required to maintain the
newly formed bone.
We are enrolling postmenopausal women that are on chronic corticosteroid therapy (prednisone
etc.) and have bone loss (osteopenia by DXA) to be a part of this four-year-long study. The
patients will receive two-year therapy with either PTH (1-34) or placebo, and for the second
part of the study subjects receive either estrogen and placebo or alendronate and placebo. We
will measure bone gain by standard bone densitometry, special x-rays of the spine and hip,
and serum and urine bone markers.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)