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Anabolic Agent

5 for Osteoporosis

Phase 2
Waitlist Available
Led By Robert Lindsay, MD, PhD
Research Sponsored by Helen Hayes Hospital
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 24 and 48 months
Awards & highlights

Study Summary

Osteoporosis is a disease that affects millions of individuals in the United States and abroad. It leads to decreased bone mass and causes an increased risk of fracture. This study will compare continuous versus cyclic treatment with teriparatide combined with alendronate, another drug for osteoporosis, or teriparatide alone in women with osteoporosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 and 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 and 48 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 density
Secondary outcome measures
HRpQCT (tibia, radius) and QCT (spine and hip)and FEA of these QCT scans
Histomorphometry of iliac crest bone biopsies

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: 5Experimental Treatment3 Interventions
Participants in this group will receive a cyclical regimen of teriparatide. Teriparatide will be administered subcutaneously in 20-mcg doses daily for 3 months. They will receive no teriparatide for the following 3 months, and then teriparatide treatment will continue for the 3 months after that. This schedule will continue for 24 months with an option to all participants to continue cyclic teriparatide for another 24 months. Biopsies will be performed at Week 7 or Month 7.5.
Group II: 4Experimental Treatment3 Interventions
Participants in this group will receive a continuous regimen of teriparatide (20 mcg delivered subcutaneously) daily for 48 months. Biopsies will be performed at Week 7 or Month 7.5. At 24 months the participants will then have the option of taking alendronate and remaining in the study for another 24 months.
Group III: 2Experimental Treatment4 Interventions
Participants in this group will have been treated with alendronate for at least 1 year prior to study entry. Upon study entry, they will receive a cyclical regimen of teriparatide, in addition to alendronate. Teriparatide will be administered subcutaneously in 20-mcg doses daily for 3 months. They will receive no teriparatide for the following 3 months, and then teriparatide treatment will continue for the 3 months after that. This schedule will continue for 24 months with an aption to all participants to continue cyclic teriparatide for another 24 months. Biopsies will be performed at Week 7 or Month 7.5.
Group IV: 1Experimental Treatment4 Interventions
Participants in this group will have been treated with alendronate for at least 1 year prior to study entry. Upon study entry, they will receive a continuous regimen of daily teriparatide (20 mcg subcutaneously) for 48 months, in addition to alendronate. Biopsies will be performed at Week 7 or Month 7.5. The participants will then have the option to be followed while taking alendronate alone for 24-48 months.
Group V: 3Active Control3 Interventions
Participants in this group will have been treated with alendronate for at least 1 year prior to study entry. Upon study entry, they will continue taking alendronate alone. Biopsies will be performed at Week 7 and then participants in this group will be offered teriparatide as part of Group 2 or 3.
Group VI: 6Active Control2 Interventions
Participants in this group will take only calcium and vitamin D supplements. Biopsies will be performed at Week 7. Participants will then be offered the standard care for osteoporosis or they may enter the study in Group 4 or 5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D3
2011
Completed Phase 4
~3590
Calcium
2014
Completed Phase 4
~4660
Alendronic acid
FDA approved
Teriparatide
FDA approved

Find a Location

Who is running the clinical trial?

Health Research, Inc.OTHER
2 Previous Clinical Trials
100 Total Patients Enrolled
2 Trials studying Osteoporosis
100 Patients Enrolled for Osteoporosis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
484 Previous Clinical Trials
1,086,867 Total Patients Enrolled
36 Trials studying Osteoporosis
40,280 Patients Enrolled for Osteoporosis
Helen Hayes HospitalLead Sponsor
5 Previous Clinical Trials
3,086 Total Patients Enrolled
2 Trials studying Osteoporosis
2,824 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.
Recent research and studies
clinicaltrials.govStudy
Cyclic Versus Daily Teriparatide on Bone Mass
Robert Lindsay 2005. "Cyclic Versus Daily Teriparatide on Bone Mass". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00668941.
All > Forteo
~7 spots leftby Apr 2025
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