Osteoporosis
Conditions
Keywords
teriparatide, Forteo, Denosumab, Prolia, bone density, treatment
Brief 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.
Detailed description
In order to maximize the early anabolic effect with teriparatide (TPTD), and to avoid the development of tachyphylaxis to the continued daily administration of TPTD beyond 6 months, cyclic therapy might be optimal. Since Denosumab (Prolia) is a potent antiresorptive agent with a rapid off-effect, it might be the optimal agent to help maximize bone gains with cyclic TPTD/antiresorptive therapy. Our primary hypothesis is that the increment in bone density of the spine by DXA will be greater in women randomized to receive the cyclic sequential regimen (three separate 6 month cycles of daily subcutaneous TPTD, each followed by one subcutaneous injection of Denosumab) compared with daily sequential therapy (18 months of daily subcutaneous TPTD followed by Denosumab therapy for 18 months).
Interventions
Standard Clinical Practice Regimen
DRUGExperimental Cyclic Regimen
Experimental Cyclic Regimen
Sponsors
Health Research, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes
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.
Exclusion criteria
are detailed below. Subjects who meet initial pre-screening criteria will present for an on site screening visit and have a full medical history, brief physical exam, BMD and lab evaluation to confirm eligibility. Osteoporosis will be defined by DXA BMD T-Score \< -2.5 at lumbar spine (at least 2 evaluable vertebrae between L1 and L4), or total hip or femoral neck. In addition, women with confirmed vertebral deformity on radiograph or lateral DXA image, or prior osteoporosis-related fracture at age \>45 along with a DXA BMD T-Score \< -1.5 at one or more skeletal sites will be eligible to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| spine bone density | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bone mineral density of the hip, wrist, total body and lateral spine and CT of arm and leg | 3 years | Bone mineral density testing of multiple skeletal sites and peripheral QCT with high resolution of the leg and arm |
Other
| Measure | Time frame | Description |
|---|---|---|
| bone turnover | 3 years | Measurement of bone formation and bone resorption |
Countries
United States
Outcome results
None listed