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

NCTNCT00221299Other id200513216

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 60 participants (actual)
Sponsor: University of California, Davis · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Sept 2005
Primary completion: Mar 2009
Completion: May 2009
First posted: 22 Sept 2005 (estimated)
Last update posted: 25 Jun 2015 (estimated)
Conditions: Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200520062007200820092010

Ph 4
Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use
NCT00221299
Sept 2005 to May 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

RisedronateDrug
Parathyroid HormoneDrug

Arms4

Active comparator
Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2)
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.
Active comparator
Group1b-rhPTH&RisendronatePlacebo
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.
Active comparator
Group2-rhPTH&Risedronate
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.
Active comparator
Group3-rhPTH-Placebo&Risedronate
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months.
Time frame · BMD changes from year 1 to year 2
Registry description
In this randomized clinical trial to determine if treatment with rhPTH (1-34) with and without risedronate will increase bone mass of the lumbar spine more than risedronate alone. This was a small pilot study and study subjects were recruited from two study sites. Our primary endpoint was change in lumbar spine BMD.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· BMD changes from year 1 to year 2

Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months.

Group	Value (percent change)	Spread
Parathyroid Hormone&Risedronate Placebo	0.85	0.10
Parathyroid Hormone&Risedronate	0.84	0.12
Parathyroid Hormone Placebo&Risedronate	0.91	0.11

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Parathyroid Hormone Injections and Risedronate Placebo Tabletsparathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year Parathyroid Hormone: 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.	–	0 / 24	0 / 24
Parthyroid Hormone Injections and Risedronte TabletsParathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year. Parathyroid Hormone: 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.	–	0 / 14	0 / 14
Parathyroid Hormone Placebo Injections and Risedronate Tabletsparathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.	–	0 / 11	0 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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