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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00887354
First received: April 23, 2009
Last updated: January 27, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 (BMD) [ Time Frame: Baseline, Week 78 ]
    Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).


Secondary Outcome Measures:
  • Change in Lumbar Spine Areal Bone Mineral Density [ Time Frame: Baseline, Week 26; Baseline, Week 52 ]
    Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).

  • Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb [ Time Frame: Baseline, Week 26; Baseline, Week 52; Baseline, Week 78 ]

    Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) .

    Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use.


  • Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire [ Time Frame: Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26 ]
    SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No).

  • Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale [ Time Frame: Baseline ]
    Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous.

  • Visual Analog Scale (VAS) [ Time Frame: 6, 12, 18, and 26 Weeks ]
    Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction.

  • Timed "Up and Go" Test [ Time Frame: 6, 12, 18, and 26 Weeks ]
    Timed "Up and Go" test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley's pain score.


Enrollment: 224
Study Start Date: April 2009
Study Completion Date: August 2015
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
  • 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Hide Study Locations
Locations
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fort Lauderdale, Florida, United States, 33316
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New Port Richey, Florida, United States, 34652
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Orlando, Florida, United States, 32804
United States, New York
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New York, New York, United States, 10075
United States, North Carolina
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Durham, North Carolina, United States, 27710
United States, North Dakota
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Fargo, North Dakota, United States, 58103
Canada, Ontario
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Toronto, Ontario, Canada, M5G 2C4
Croatia
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Zagreb, Croatia, 10000
Czech Republic
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Klatovy, Czech Republic, 33938
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Prague, Czech Republic, 140 59
Denmark
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Odense, Denmark, 5000
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Viborg, Denmark, 8800
France
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Orleans, France, 45032
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Paris, France, 75679
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Saint-Etienne, France, 42055
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Villeurbanne, France, 69100
Germany
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Göttingen, Germany, 37075
Greece
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Thessaloniki, Greece, 56429
Italy
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Milano, Italy, 20122
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Rome, Italy, 00133
Mexico
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Mexicali, Mexico, 21200
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Monterrey, Mexico, 64460
Norway
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Oslo, Norway, 0407
Spain
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Barcelona, Spain, 08025
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Girona, Spain, 17007
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Madrid, Spain, 28041
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Marbella, Spain, 29600
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Sevilla, Spain, 41013
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00887354     History of Changes
Other Study ID Numbers: 12400
B3D-EW-GHDK ( Other Identifier: Eli Lilly and Company )
Study First Received: April 23, 2009
Results First Received: July 15, 2016
Last Updated: January 27, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Keywords provided by Eli Lilly and Company:
Low bone mass
Recent pertrochanteric hip fracture

Additional relevant MeSH terms:
Osteoporosis
Hip Fractures
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Vitamin D
Teriparatide
Risedronate Sodium
Etidronic Acid
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 19, 2017