A Phase 2 interventional study of Teriparatide and Alendronate in Osteoporosis, sponsored by Helen Hayes Hospital. Status unknown at 1 site in United States. Open to female participants aged 45 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-10.
Sponsored by Helen Hayes Hospital · Phase 2, Interventional, and Treatment
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.
Osteoporosis is a serious bone disease that has become an important public health problem. It causes significant loss of bone mass and increases the risk of both fracture and architectural problems with the skeleton. Until recently, the treatments available for osteoporosis primarily prevented further deterioration of bone by reducing the rate of remodeling within the skeleton. This can reduce the risk of fracture by approximately 50%. Teriparatide is a new type of drug for people with osteoporosis who are at high risk of fracture. Teriparatide stimulates bone remodeling and can correct the underlying architectural and bone mass abnormalities that are characteristic of osteoporosis. This study will compare continuous versus cyclic treatment with teriparatide combined with alendronate, another drug for osteoporosis, or teriparatide alone in women with osteoporosis.
All participants have completed a parent study of two years that included a screening visit with a physical exam, blood draw, x-rays, EKG, and distribution of calcium and vitamin D supplements. Participants will be separated into two groups according to the treatment they have undergone over the year prior to study entry. Participants who have taken alendronate for at least 1 year prior to study entry will be assigned to Protocol 1. Participants who have not previously taken alendronate will be assigned to Protocol 2. Participants in both protocols will be randomly assigned to one of the following three biopsy groups: pre-treatment; early; or late. Participants in the pre-treatment biopsy group will have a bone biopsy before treatment begins. Those participants in the early biopsy group will have a biopsy at Week 7 of treatment, and those in the late group will have a biopsy at Month 7.5 of treatment.
Participants will also be randomly assigned to one of three treatment schedules. Participants in Protocol 1 may be assigned to receive alendronate alone for 24 months; teriparatide daily plus alendronate for 24 months; or teriparatide daily on and off for 3 months at a time plus alendronate for 24 months. Participants in Protocol 2 may be assigned to receive only the supplements they were given during the screening visit; teriparatide daily plus alendronate for 24 months; or teriparatide daily on and off for 3 months at a time for 24 months. Participants will attend assessment visits at Weeks 4 and 7 and Months 3, 5, 6, 7.5, 9, 12, 15, 18, 21, and 24. Visits may include bone turnover measurements, bone mass scans, walking tests, questionnaires, CT scans, and blood draws.
A recently funded extension study will extend the treatment period from 24 to 48 months for all consenting. If the individual was assigned to teriparatide daily (with or without alendronate), they will be given alendronate for the 24 to 48 month time period. If the individual was assigned to cyclic teriparatide, they will continue cyclic therapy foro the 24-48 month period (with or without alendronate).
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's planned enrollment of 140 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Helen Hayes Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Teriparatide · Drug: Alendronate · Dietary Supplement: Calcium · Dietary Supplement: Vitamin D3
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.
Drug: Teriparatide · Drug: Alendronate · Dietary Supplement: Calcium · Dietary Supplement: Vitamin D3
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.
Drug: Alendronate · Dietary Supplement: Calcium · Dietary Supplement: Vitamin D3
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.
Drug: Teriparatide · Dietary Supplement: Calcium · Dietary Supplement: Vitamin D3
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.
Drug: Teriparatide · Dietary Supplement: Calcium · Dietary Supplement: Vitamin D3
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.
Dietary Supplement: Calcium · Dietary Supplement: Vitamin D3
Teriparatide will be given subcutaneously in 20-mcg doses either continuously or cyclically.
Participants will take 70 mg per week of alendronate for 48 months.
Calcium supplements will be administered in varied amounts for all participants, but each participant will take enough to bring her total daily calcium intake to 1,200 mg.
Vitamin D3 supplements will be administered in varied amounts for all participants, but each participant will take enough to bring her total daily intake to 1,200 mg.
Bone density
Time frame: 24 and 48 months
Histomorphometry of iliac crest bone biopsies
Time frame: Measured at Week 7 and Month 7
HRpQCT (tibia, radius) and QCT (spine and hip)and FEA of these QCT scans
Time frame: 48 months
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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