NCT00887354·Phase 4·INTERVENTIONAL

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

Teriparatide Other Completed

Status

Completed

Phase

Phase 4

Enrollment

224

Locations

Results

Posted

Publications

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Teriparatide

Administered subcutaneously

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.

Timeline

From registration to results.

First posted
Apr 24, 2009
Study start
Apr 2009
Primary completion
Aug 2015
Study completion
Aug 2015
Results posted
Jan 9, 2017
Registry updated
Sep 25, 2019

Outcomes

What the study measures.

Primary outcomes

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 outcomes

Change in Lumbar Spine Areal Bone Mineral Density

Time frame · Baseline, Week 26; Baseline, Week 52

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.

Eligibility

Who can take part.

Minimum age: 50 Years
Maximum age: Not reported
Sex: ALL
Healthy volunteers: No

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

Study locations

28 registered sites.

Canada · Croatia · Czechia · Denmark · France · Germany · Greece · Italy · Mexico · Norway · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.

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

New Port Richey, Florida, United States

Orlando, Florida, United States

New York, New York, United States

Durham, North Carolina, United States

Fargo, North Dakota, United States

Toronto, Ontario, Canada

Zagreb, Croatia

Klatovy, Czechia

Prague, Czechia

Odense, Denmark

Viborg, Denmark

Orléans, France

Paris, France

Saint-Etienne, France

Villeurbanne, France

Göttingen, Germany

Thessaloniki, Greece

Milan, Italy

Rome, Italy

Mexicali, Mexico

Monterrey, Mexico

Oslo, Norway

Barcelona, Spain

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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