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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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

Eligible Conditions

Osteoporosis

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

bone mineral density of the hip, wrist, total body and lateral spine and CT of arm and leg

Other study objectives

bone turnover

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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).

0 / 1Eligibility criteria met