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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00887354
First received: April 23, 2009
Last updated: April 1, 2014
Last verified: April 2014
  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:


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: August 2015
Estimated Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 28 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: April 1, 2014
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
Bone Diseases
Bone Diseases, Metabolic
Femoral Fractures
Fractures, Bone
Hip Injuries
Leg Injuries
Musculoskeletal Diseases
Wounds and Injuries
Risedronic acid
Teriparatide
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014