A Phase 4 interventional study of denosumab and teriparatide 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 2021-02-09.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment
The aim of the study is to assess the effect of an antiresorptive medication in combination with standard dose or alternate dose teriparatide. The study extension will evaluate the effect of one-dose of zoledronic acid after the teriparatide/denosumab combination.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 76 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.
Exclusion Criteria:
teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
Drug: denosumab · Drug: teriparatide · Drug: Zoledronic acid
teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
Drug: denosumab · Drug: teriparatide · Drug: Zoledronic acid
denosumab subcutaneous injection
Also known as: Prolia
teriparatide daily subcutaneous injection
Also known as: Forteo
zoledronic acid infusion
Also known as: Reclast
Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)
Time frame: Baseline and 42 months
| Milestone | Standard Dose Teriparatide | High Dose Teriparatide |
|---|---|---|
| Started | 39 | 37 |
| Completed | 31 | 29 |
| Not completed | 8 | 8 |
| Milestone | Standard Dose Teriparatide | High Dose Teriparatide |
|---|---|---|
| Started | 27 | 26 |
| Completed | 26 | 26 |
| Not completed | 1 | 0 |
| percent change in BMD | Standard Dose Teriparatide | High Dose Teriparatide |
|---|---|---|
| Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA) | 7.69 ± 4.66 | 12.70 ± 5.54 |
Collected over 3.5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Dose Teriparatide | 0/39 (0%) | 9/39 (23.1%) | 0/39 (0%) |
| High Dose Teriparatide | 0/37 (0%) | 2/37 (5.4%) | 2/37 (5.4%) |
| Event | Standard Dose Teriparatide | High Dose Teriparatide |
|---|---|---|
| wrist fractureMusculoskeletal and connective tissue disorders | 2/39 | 1/37 |
| breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/39 | 0/37 |
| anal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/39 | 1/37 |
| clavicle fractureMusculoskeletal and connective tissue disorders | 1/39 | 0/37 |
| fibula avulsion fractureMusculoskeletal and connective tissue disorders | 1/39 | 0/37 |
| humeral fractureMusculoskeletal and connective tissue disorders | 1/39 | 0/37 |
| kidney cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/39 | 0/37 |
| pancreatitisEndocrine disorders | 1/39 | 0/37 |
| rib fractureMusculoskeletal and connective tissue disorders | 1/39 | 0/37 |
| shoulder dislocationMusculoskeletal and connective tissue disorders | 1/39 | 0/37 |
| Event | Standard Dose Teriparatide | High Dose Teriparatide |
|---|---|---|
| back painMusculoskeletal and connective tissue disorders | 0/39 | 2/37 |
Includes all subjects who completed at least 1 post-baseline visit.
| Age, Continuous(years) | Standard Dose Teriparatide | High Dose Teriparatide | Total |
|---|---|---|---|
| Mean | 65.9 ± 7.0 | 67.0 ± 7.3 | 66.4 ± 7.1 |
| Sex: Female, Male(Participants) | Standard Dose Teriparatide | High Dose Teriparatide | Total |
|---|---|---|---|
| Female | 35 | 34 | 69 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Standard Dose Teriparatide | High Dose Teriparatide | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 34 | 33 | 67 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Standard Dose Teriparatide | High Dose Teriparatide | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 33 | 33 | 66 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital