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

Lilly

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Dietary Supplement: Vitamin D; Drug: Risedronate; Drug: Teriparatide; Drug: Placebo; Dietary Supplement: Calcium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00887354

B3D-EW-GHDK (Other Identifier)

12400

Details and patient eligibility

About

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 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.

Enrollment: 224 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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224 participants in 2 patient groups

Teriparatide

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Teriparatide

Dietary Supplement: Calcium

Dietary Supplement: Vitamin D

Risedronate

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Risedronate

Dietary Supplement: Calcium

Dietary Supplement: Vitamin D