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

NCT00221299 | Completed Phase 4 Results

• 1 other identifier: 200513216
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

Osteoporosis; Steroids; Prednisone

Outcome Measures

Primary Outcomes (1)

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

  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.

  BMD changes from year 1 to year 2

Study Arms (4)

Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2)

ACTIVE COMPARATOR

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.

Drug: Risedronate; Drug: Parathyroid Hormone

Group1b-rhPTH&RisendronatePlacebo

ACTIVE COMPARATOR

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.

Drug: Parathyroid Hormone

Group2-rhPTH&Risedronate

ACTIVE COMPARATOR

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.

Drug: Risedronate; Drug: Parathyroid Hormone

Group3-rhPTH-Placebo&Risedronate

ACTIVE COMPARATOR

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.

Drug: Risedronate

Interventions

Risedronate DRUG

One 35mg tab of risedronate/placebo taken once a week for one year.

Also known as: Actonel, NDC# 0149-0472-04

Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2); Group2-rhPTH&Risedronate; Group3-rhPTH-Placebo&Risedronate

Parathyroid Hormone DRUG

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.

Also known as: Forteo, PTH, rhPTH 1-34, NDC# 0002-8971-01

Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2); Group1b-rhPTH&RisendronatePlacebo; Group2-rhPTH&Risedronate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, Davis: lead
• University of California, San Francisco: collaborator

Study Sites (1)

UC Davis General Medicine Research Clinic

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Risedronic Acid; Parathyroid Hormone; Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Nancy E. Lane MD, Director, Center for Musculoskeletal Health
• Organization: Unversity of California Davis

nancy.lane@ucdmc.ucdavis.edu

916 734-0753

Study Officials

• Nancy E Lane, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 25, 2015
• Results First Posted: June 25, 2015

Record last verified: 2015-06

Locations

US (1)