Approval Probability
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Adjusted LOA
ML Risk
Parathyroid Hormone · 2 trials · 2 indications
Change in density of the fracture in the sternum at different time frames compared with baseline at 6 weeks.
BMD was measured by Dual X-ray Absorptiometry (DXA).
| Arm | Type | Description |
|---|---|---|
| Control | PLACEBO_COMPARATOR | Control patients treated with placebo. |
| Intervention | ACTIVE_COMPARATOR | Daily injection with Parathyroid hormone |
| PTH (1-84) | EXPERIMENTAL | - |
| Risedronate | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Parathyroid hormone | DRUG | 100 microgram daily. S.c |
| Placebo | DRUG | Placebo; saline injection. |
| Parathyroid Hormone (PTH) | DRUG | Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen. |
| Risedronate | DRUG | Orally once weekly as one 35 mg tablet. |
Inclusion Criteria: * Full sternotomy * Not in chronic, systemic corticosteroid treatment. * No Plavix treatment 5 days prior to surgery * No known bone metabolic diseases. * Replete vitamin D status (plasma 25-hydroxyvitamin D \>50 nmol/l) * Normal serum levels of Calcium, Phosphate, inorganic, al...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Precision BioSciences, Inc. | DTIL | 1 | N/A | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | - | Undisclosed |
Parathyroid Hormone is an investigational small molecule being developed for osteoporosis and for disruption or dehiscence of closure of the sternum or sternotomy. It is in Phase 3 clinical development, though the trials listed have been completed.
Parathyroid Hormone is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is currently in Phase 3 clinical development for osteoporosis and sternal closure complications.
Parathyroid Hormone is in Phase 3 clinical development. It is an investigational drug, not yet approved, and is being studied for osteoporosis and for disruption or dehiscence of closure of the sternum or sternotomy.
Parathyroid Hormone has two completed Phase 3 trials: NCT00365456, a sequential treatment study in 407 postmenopausal women with primary osteoporosis in Denmark, and NCT01466829, a study in 20 male cardiac surgery patients with sternal closure disruption in Denmark.
Parathyroid Hormone is a small molecule that acts as a parathyroid hormone, a key regulator of calcium and phosphate metabolism. It is being studied for its effects on bone, particularly in osteoporosis and sternal wound healing.