A Phase 4 interventional study of Teriparatide 40-mcg subcutaneous injection and Denosumab Injection in Postmenopausal Osteoporosis, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to female participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-27.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 27 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Must satisfy A and B and C below:
A. Women aged 45+
B. Postmenopausal
C. Osteoporotic with high risk of fracture
Exclusion Criteria:
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Drug: Teriparatide 40-mcg subcutaneous injection · Drug: Denosumab Injection
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Drug: Teriparatide 40-mcg subcutaneous injection · Drug: Alendronate Oral Tablet
Also known as: Forteo®
One-time Denosumab injection
weekly alendronate for 8 weeks
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
| Milestone | Denosumab 60mg Subcutaneous Injection | Alendronate 70mg Weekly x 8 Weeks |
|---|---|---|
| Started | 13 | 14 |
| Completed | 12 | 13 |
| Not completed | 1 | 1 |
The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.
| percentage of change in CTX | Denosumab 60mg Subcutaneous Injection | Alendronate 70mg Weekly x 8 Weeks |
|---|---|---|
| Bone Turnover Marker (Blood Sample) | -7 ± 11 | 43 ± 29 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Denosumab 60mg Subcutaneous Injection | — | 1/12 (8.3%) | 0/12 (0%) |
| Alendronate 70mg Weekly x 8 Weeks | — | 1/13 (7.7%) | 0/13 (0%) |
| Event | Denosumab 60mg Subcutaneous Injection | Alendronate 70mg Weekly x 8 Weeks |
|---|---|---|
| LightheadednessEndocrine disorders | 1/12 | 0/13 |
| SyncopeEndocrine disorders | 0/12 | 1/13 |
| Age, Continuous(years) | Denosumab 60mg Subcutaneous Injection | Alendronate 70mg Weekly x 8 Weeks | Total |
|---|---|---|---|
| Mean | 66 ± 7 | 66 ± 8 | 66 ± 8 |
| Sex: Female, Male(Participants) | Denosumab 60mg Subcutaneous Injection | Alendronate 70mg Weekly x 8 Weeks | Total |
|---|---|---|---|
| Female | 12 | 13 | 25 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Denosumab 60mg Subcutaneous Injection | Alendronate 70mg Weekly x 8 Weeks | Total |
|---|---|---|---|
| United States | 12 | 13 | 25 |
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital