NCT06973109 - Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

November 30, 2026

Study Completion Date

June 30, 2027

Conditions

Osteoporosis, Post-menopausal

Interventions

DRUG

Romosozumab

Monthly subcutaneous injection (210 mg total dose) administered as two separate 105 mg injections, one per arm. Administered for 12 months to female patients ≥65 years undergoing spine surgery.

DRUG

Alendronate (Fosamax)

Weekly oral dose (70 mg) administered for 12 months. Used as active comparator in control arm of study.

DRUG

Placebo Romosozumab

Monthly subcutaneous injections mimicking romosozumab in appearance and administration schedule. Administered to control group.

DRUG

Placebo Alendronate

Weekly oral placebo pill mimicking alendronate. Administered to treatment group.

Trial Locations (1)

15213

University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital, Pittsburgh