Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use

Completed · Phase 4 · Has a placebo group

Conditions studied: Osteoporosis

In brief

The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH), either alone or with risedronate, will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use. During the second year, the study will also look at whether taking risedronate will preserve the bone thickness created by one year of rhPTH 1-34 treatment.

Key facts

Study ID

NCT00221299

Run by

University of California, Davis

People needed

60

Starts

2005-09-01

Expected to finish

2009-05-01

Last updated by the study team

2015-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women, greater than 18 years of age with a history of glucocorticoid therapy with prednisone ≥ 7.5mg/d for 6 months, and currently on prednisone ≥ 5mg /day.
• DXA of the lumbar spine (L1-L4) or total hip or femoral neck T score ≤ -1.5 with or without a prevalent vertebral fracture. (The T score is the number of standard deviations above or below the population mean for young, normal pre-menopausal females age 30).
• Investigators are satisfied that that there is no physical condition that would prevent a patient from receiving the proposed treatment regimens.
• Patient is ambulatory and able to return to the site of the investigation at specified time during the study.
• The patient is willing to participate in the proposed study as evidenced by signing an informed consent.
• Women of childbearing age are willing to use 2 forms of contraception during the entire study period.
• Have at least one analyzable BMD site: lumbar spine and/or proximal femur

You may not qualify if…

• Generalized disease of bone other than related to a rheumatic disease and glucocorticoid-induced osteoporosis including: hyperparathyroidism, hypoparathyroidism, Paget's disease of bone
• Diseases that may affect bone metabolism including: alcoholism, hyperthyroidism, renal impairment (creatinine > 2.5mg/dl) or hepatic impairment (SGOT levels > 2x upper limit of normal
• Urinary excretion of calcium > 400mg/day
• History of drug abuse
• Previous use of alendronate within 6 months prior to the study
• Previous use of risedronate, hormone replacement therapy or calcitonin within 2 months prior to the study
• History of unstable cardiovascular disease or uncontrolled hypertension
• Severe scoliosis, greater than 2 lumbar fractures, or spinal surgery such that a precise bone mass measurement could be affected
• History of gastrointestinal intolerance to bisphosphonates
• History of cancer within 5 years of the study
• Patients on glucocorticoids for organ transplantation

Where it is running

• UC Davis General Medicine Research Clinic — Sacramento, California, United States

Full record on ClinicalTrials.gov

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