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

• 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 ]

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.

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.

• Drug: Teriparatide
  Administered subcutaneously
  Other Names:

  • Forteo
  • Forsteo
  • LY333334
• 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.

• 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.

  Interventions:

  • Drug: Teriparatide
  • Drug: Placebo
  • Dietary Supplement: Calcium
  • Dietary Supplement: Vitamin D
• 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.

  Interventions:

  • Drug: Risedronate
  • Drug: Placebo
  • Dietary Supplement: Calcium
  • Dietary Supplement: Vitamin D

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