Postmenopausal Osteoporosis
Conditions
Keywords
osteoporosis, postmenopausal, denosumab, teriparatide, alendronate, Forteo®, Prolia®
Brief summary
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.
Interventions
DRUGTeriparatide 40-mcg subcutaneous injection
One-time Denosumab injection
weekly alendronate for 8 weeks
Sponsors
Massachusetts General Hospital
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
Must satisfy A and B and C below: A. Women aged 45+ B. Postmenopausal C. Osteoporotic with high risk of fracture
Exclusion criteria
* History of significant hepatic, renal, cardiovascular, malignant disease, or conditions with impaired immune system * Current alcohol or substance abuse * Major psychiatric disorders * Abnormal calcium level, elevated PTH, vitamin D deficiency, or anemia * Known congenital or acquired bone disease other than osteoporosis * Current use or past use in the past 12 months of oral bisphosphonates * Current use or use in the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin * Use of oral or parenteral glucocorticoids for more than 14 days in the past 6 months * Any current or previous use of strontium or intravenous bisphosphonates * Sensitivity to cell-derived drug products or teriparatide * Extensive dental work involving dental extraction or dental implant within the past 2 months or in the upcoming 2 months * Inability to sit upright for 30 minutes * Esophageal abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Turnover Marker (Blood Sample) | 8 weeks | The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Denosumab 60mg Subcutaneous Injection Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Teriparatide 40-mcg subcutaneous injection | 12 |
| Alendronate 70mg Weekly x 8 Weeks Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Teriparatide 40-mcg subcutaneous injection | 13 |
| Total | 25 |
Baseline characteristics
| Characteristic | Denosumab 60mg Subcutaneous Injection | Alendronate 70mg Weekly x 8 Weeks | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 7 | 66 years STANDARD_DEVIATION 8 | 66 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 13 |
| serious Total, serious adverse events | 1 / 12 | 1 / 13 |
Outcome results
Primary
Bone Turnover Marker (Blood Sample)
The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab 60mg Subcutaneous Injection | Bone Turnover Marker (Blood Sample) | -7 percentage of change in CTX | Standard Deviation 11 |
| Alendronate 70mg Weekly x 8 Weeks | Bone Turnover Marker (Blood Sample) | 43 percentage of change in CTX | Standard Deviation 29 |