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Monoclonal Antibodies

Experimental (cyclic) regimen for Osteoporosis

Phase 4
Waitlist Available
Led By Felicia Cosman, M.D.
Research Sponsored by Health Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Inclusion Criteria:Subjects should be postmenopausal >age 45, and of any racial origin. They must not be on any osteoporosis medication. They should be willing to participate for the duration of the study and have no physical or psychological illness that would prohibit them from participating. Pregnant women, protected individuals (institutionalized), and those unable to give informed consent will not be recruited.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This is a three-year study to evaluate the effect of sequential therapy of Forteo (teriparatide) and denosumab on bone density at the spine, hip, leg and forearm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
spine bone density
Secondary outcome measures
bone mineral density of the hip, wrist, total body and lateral spine and CT of arm and leg
Other outcome measures
bone turnover

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental (cyclic) regimenExperimental Treatment1 Intervention
Experimental (Cyclic) Regimen: three separate 6-month cycles of daily subcutaneous Forteo, each followed by one subcutaneous injection of Prolia (Forteo from 0 to 6 months, and then from 12 to 18 months and then from 24 to 30 months, for a total dose of 18 months; 3 injections of Prolia at 6, 18 and 30 months).
Group II: Standard Clinical Practice RegimenActive Control1 Intervention
Standard Clinical Practice (Daily) Regimen: 18 months of daily subcutaneous Forteo followed by denosumab therapy for 18 months (18 months of Forteo then 3 injections of Prolia at 18, 24 and 30 months).

Find a Location

Who is running the clinical trial?

Health Research, Inc.Lead Sponsor
2 Previous Clinical Trials
180 Total Patients Enrolled
2 Trials studying Osteoporosis
180 Patients Enrolled for Osteoporosis
Felicia Cosman, M.D.Principal InvestigatorHelen Hayes Hospital
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Osteoporosis
40 Patients Enrolled for Osteoporosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
Helen Hayes Hospital
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

The cost of treatment is too expensive. I have not started any treatment.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Please explain the details of the trial. How many visits would have to be made? Can anything be done in California?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab
Felicia Cosman, M.D. 2013. "The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02130973.
All > Osteoporosis > Forteo
~5 spots leftby Apr 2025
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