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Osteoporosis Agent

Denosumab alone for Osteoporosis

Phase 4
Waitlist Available
Research Sponsored by Felicia Cosman, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12, 18 months
Awards & highlights

Study Summary

This trial will compare the effects of two different treatments on postmenopausal women's bone mineral density over 18 months. The primary outcome will be group differences in bone mineral density of the total hip and lumbar spine at 18 months.

Eligible Conditions
  • Osteoporosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12, 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12, 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bone mineral density changes at total hip and lumbar spine
Secondary outcome measures
Bone mineral density changes in increments
Differences in biochemical bone turnover markers
Trabecular Bone Score changes
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Denosumab aloneActive Control1 Intervention
3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment.
Group II: Combination therapyActive Control2 Interventions
3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment, with added abaloparatide 80 mcg subcutaneously daily, started within 6 months of the last denosumab treatment, for a total of 18 months.

Find a Location

Who is running the clinical trial?

Felicia Cosman, MDLead Sponsor
Crozer-Keystone Health SystemOTHER
4 Previous Clinical Trials
224 Total Patients Enrolled
Radius Health, Inc.Industry Sponsor
14 Previous Clinical Trials
27,081 Total Patients Enrolled
11 Trials studying Osteoporosis
27,006 Patients Enrolled for Osteoporosis
~16 spots leftby Jun 2025
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