Clinical trial NCT00221299
Conditions: Osteoporosis
Keywords: Osteoporosis Steroids Prednisone
Sponsor: University of California, Davis
Start date: 2005-09-01; Completion date: 2009-05-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
Dr. Nancy Lane and colleagues at the University of California, Davis and University of California, San Francisco will be conducting this 2-year study of human parathyroid hormone (rhPTH 1-34) alone, and rhPTH (1-34) with risedronate compared to risedronate alone in men and women with osteopenia on chronic low dose glucocorticoids (GC). This is an investigator-initiated study funded by Aventis Pharmaceuticals.

The study will be divided into 2 phases. All study subjects will receive supplemental calcium citrate and Vitamin D during the 2-year study. In year one subjects will be randomly assigned to receive PTH (subcutaneously daily) or placebo and risedronate tablets or placebo. In year two, PTH will be stopped and subjects in group 1 will be re-randomized to receive risedronate tablets or placebo. Subjects in group 2 and 3 will continue on risedronate tablets.

In year one of the study, subjects were randomly assigned to one of the following treatment groups.

1. Group 1: rhPTH (1-34) (20ug subcutaneously daily) + riesdronate placebo tablets
2. Group 2: rhPTh (1-34) (20ug subcutaneously daily) + risedronate tablets (35mg/wk)
3. Group 3: rhPTh placebo (subcutaneous injections of normal saline) + risedronate tablets (35mg/wk)

In year two of the study, beginning at the 12 month timepoint

1. Group 1 subjects were re-randomized to either:

   Group 1a: risedronate (35mg/wk) or Group 1b: risedronate placebo
2. Group 2 subjects continued risedronate (35mg/wk)
3. Group 3 subjects continued risedronate (35mg/wk)

Potential study subjects will have dual x-ray absorptiometry measurements (DEXA) of the spine and hip at the screening visit. Those study subjects who meet the inclusion criteria will be invited back for a baseline visit.

DEXA scans of the spine, hip, and forearm will be done at Baseline visit, 6-month, 12-month, 18-month, and 24-month follow-up visits. DEXA scan of the spine, hip, and forearm takes approximately 20 minutes to complete. To assess incident vertebral and non-vertebral fractures, lateral thoracic and lumbar spine evaluation using Instant Vertebral Assessment \[IVA\] will be done at Baseline, 12-month, and 24-month follow-up visits.

The specific aims of the study are as follows:

1. To determine if changes in bone mineral density in the spine and hip caused by 1 year of treatment with rhPTH (1-34) alone then followed by risedronate or rhPTH (1-34) with risedronate are greater than PTH placebo and risedronate in patients with GIO who are taking calcium, MVIs and chronic low doses of glucocorticoids.
2. To determine if risedronate will preserve the high bone mass state created by 1 year of rhPTH (1-34) treatment.
3. To determine the association of biochemical markers of bone turnover with rhPTH (1-34) and risedronate both during and after treatment.
4. To compare, as possible, the fracture incidence between the rhPTH (1-34) alone followed by risedronate, and rhPTH (1-34) with risedronate compared to risedronate + placebo groups.

Arms: arm 1: First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - re-randomized to risedronate (35mg/wk) tablets for second year. arm 2: First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - continue on risedronate placebo tablets for second year. arm 3: First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year. arm 4: First phase (year 1) - parathyroid hormone (rhPTH 1-34), placebo SC injections of normal saline daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.
Interventions: intervention 1: Risedronate intervention 2: Parathyroid Hormone
Intervention descriptions: intervention 1: One 35mg tab of risedronate/placebo taken once a week for one year. intervention 2: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.

Protocol documents: