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Also known as Parathyroid Hormone (PTH), Preotact®
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...
Parathyroid Hormone (PTH) is being studied for two indications: disruption or dehiscence of closure of the sternum or sternotomy, and osteoporosis. It is an investigational therapy in Phase 3 development and has not been approved for commercial use. The sternotomy research focuses on cardiac surgery patients, while the osteoporosis research focuses on postmenopausal women with primary osteoporosis.
Parathyroid Hormone (PTH) targets PTH1R, the parathyroid hormone 1 receptor. It acts as an agonist at this receptor. By binding to and activating PTH1R, the drug mimics the action of endogenous parathyroid hormone, which regulates calcium and phosphate metabolism and plays a central role in bone turnover and skeletal repair.
Parathyroid Hormone (PTH) is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor responsible for advancing this investigational therapy through clinical development in its studied indications.
Parathyroid Hormone (PTH) is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 3 program includes completed trials in sternotomy patients and in postmenopausal women with primary osteoporosis.
Parathyroid Hormone (PTH) has been evaluated in two completed Phase 3 trials. NCT01466829 studied treatment with PTH after sternotomy in cardiac surgery patients in Denmark. NCT00365456 studied sequential treatment of postmenopausal women with primary osteoporosis, also in Denmark, and enrolled 407 participants. Both trials were randomized, double-blind, and placebo-controlled.
Yes, Parathyroid Hormone and Parathyroid Hormone (PTH) refer to the same drug asset. PTH is simply the abbreviated form of the name. Both names describe the same investigational therapy developed by Takeda Pharmaceutical Company Limited for sternotomy disruption or dehiscence and osteoporosis.