A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture - Full Text View

Purpose

This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent pertrochanteric hip fracture.

Condition	Intervention	Phase
Osteoporosis	Drug: Teriparatide Drug: Risedronate Drug: Placebo Dietary Supplement: Calcium Dietary Supplement: Vitamin D	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparison of the Effects of Teriparatide With Those of Risedronate on Lumbar Spine BMD (Bone Mineral Density) in Men and Postmenopausal Women With Low Bone Mass and a Recent Pertrochanteric Hip Fracture

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Calcium Fractures Hip Injuries and Disorders Minerals Osteoporosis Vitamin D

Drug Information available for: Calcium Gluconate Vitamin D Teriparatide Teriparatide acetate Risedronate sodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change in Lumbar Spine Areal Bone Mineral Density [ Time Frame: Baseline, 18 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Lumbar Spine Areal Bone Mineral Density [ Time Frame: Baseline, 26 Weeks, 12 Months ] [ Designated as safety issue: No ]
Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb [ Time Frame: Baseline, 26 Weeks, 12 Months, 18 Months ] [ Designated as safety issue: No ]
Short form-36 (SF-36) Questionnaire [ Time Frame: Baseline, 6, 12, 18, and 26 Weeks of Treatment ] [ Designated as safety issue: No ]
Modification of the Charnley's Pain Scale [ Time Frame: Baseline, 6, 12, 18, and 26 Weeks ] [ Designated as safety issue: No ]
Timed "Up and Go" Test [ Time Frame: Baseline, 6, 12, 18, and 26 Weeks ] [ Designated as safety issue: No ]
Visual Analog Scale [ Time Frame: Baseline, 6, 12, 18, and 26 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	242
Study Start Date:	April 2009
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Teriparatide 20 micrograms (mcg) a day by subcutaneous injection throughout study. Placebo oral tablets once a week, to match the active comparator weekly dose, during the double-blind, double-dummy phase only.	Drug: Teriparatide Administered subcutaneously Other Names: Forteo Forsteo LY333334 Drug: Placebo Weekly: Administered orally Daily: Administered subcutaneously Dietary Supplement: Calcium Approximately 500 to 1000 mg/day administered orally throughout study. Dietary Supplement: Vitamin D Approximately 800 International Units per day (IU/day) administered orally throughout study.
Active Comparator: Risedronate 35 milligrams (mg) risedronate sodium orally once weekly throughout study. Daily placebo injection, to match the daily experimental drug dose, during the double-blind, double-dummy phase only.	Drug: Risedronate Administered orally Drug: Placebo Weekly: Administered orally Daily: Administered subcutaneously Dietary Supplement: Calcium Approximately 500 to 1000 mg/day administered orally throughout study. Dietary Supplement: Vitamin D Approximately 800 International Units per day (IU/day) administered orally throughout study.

Detailed Description:

The study has 3 periods: a screening phase, a double-blind, double-dummy treatment phase from the time of randomization to the 26 weeks visit, and an open-label treatment phase of approximately 12 month duration, where participants will continue treatment with the same study drug that they were randomized to.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and postmenopausal women aged ≥50 who have sustained a unilateral, fracture of the trochanteric region
Lumbar spine BMD and/or femoral neck BMD and/or total hip BMD measurement of the contra lateral hip at least 2.0 SDs (standard deviation) below the average bone mass for young women and men

Exclusion Criteria:

Clinically significant abnormal laboratory values
History of unresolved skeletal diseases that affect bone metabolism
Polytrauma participants and participants with fractures at more than one site

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887354

Contacts

Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Show 55 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM eastern time (UTC/GMT-5hours, EST)

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00887354 History of Changes
Other Study ID Numbers:	12400, B3D-EW-GHDK
Study First Received:	April 23, 2009
Last Updated:	May 14, 2013
Health Authority:	Austria: Federal Office for Safety in Health Care Canada: Health Canada Croatia: Ethics Committee Czech Republic: State Institute for Drug Control Finland: Ethics Committee France: Institutional Ethical Committee Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Ireland: Ministry of Health Norway: Ethics Committee Spain: Spanish Agency of Medicines Italy: Ethics Committee Denmark: Danish Medicines Agency Mexico: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Sweden: Institutional Review Board

Keywords provided by Eli Lilly and Company:

Low bone mass
Recent pertrochanteric hip fracture

Additional relevant MeSH terms:

Hip Fractures
Osteoporosis
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Vitamin D

Teriparatide
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013

A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture (MOVE)