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

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00887354

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, weekly Drug: Placebo, daily	Phase IV

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement Minerals Osteoporosis

Drug Information available for: Teriparatide Teriparatide acetate Risedronic acid Risedronate sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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

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:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Teriparatide: Experimental	Drug: Teriparatide 20 micrograms a day subcutaneous injection for 18 months Drug: Placebo, weekly Placebo oral tablets once a week, to match the active comparator weekly dose, during the double-blind, double-dummy phase only (for 26 weeks)
Risedronate: Active Comparator	Drug: Risedronate 35 mg risedronate sodium oral once weekly for 18 months Drug: Placebo, daily Daily placebo injection, to match the daily experimental drug dose, during the double-blind, double-dummy phase only (for 26 weeks)

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 patients will continue treatment with the same study drug that they were randomized to.

Eligibility

Ages Eligible for Study:	50 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and postmenopausal women aged 50 to 78 years 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 patients and patients 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

Locations

Spain
For additional information regarding the 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.	Not yet recruiting
Sevilla, Spain, 41013
Contact: Eli Lilly
For additional information regarding the 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.	Recruiting
Madrid, Spain, 28041
Contact: Eli Lilly

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 ( Chief Medical Officer )
Study ID Numbers:	12400, B3D-EW-GHDK
Study First Received:	April 23, 2009
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00887354 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Spain: Spanish Agency of Medicines; Italy: Ethics Committee; Denmark: Danish Medicines Agency; Mexico: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Eli Lilly and Company:

Low bone mass
Recent pertrochanteric hip fracture

Study placed in the following topic categories:

Teriparatide
Fractures, Bone
Wounds and Injuries
Calcium Channel Blockers
Osteoporosis
Disorders of Environmental Origin
Bone Diseases, Metabolic
Bone Density Conservation Agents

Cardiovascular Agents
Bone Diseases
Calcium, Dietary
Hip Fractures
Femoral Fractures
Musculoskeletal Diseases
Leg Injuries
Risedronic acid

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Teriparatide
Physiological Effects of Drugs
Fractures, Bone
Wounds and Injuries
Calcium Channel Blockers
Osteoporosis
Disorders of Environmental Origin
Bone Density Conservation Agents
Bone Diseases, Metabolic
Cardiovascular Agents

Hip Injuries
Bone Diseases
Pharmacologic Actions
Membrane Transport Modulators
Hip Fractures
Femoral Fractures
Musculoskeletal Diseases
Therapeutic Uses
Leg Injuries
Risedronic acid

ClinicalTrials.gov processed this record on May 06, 2009