Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture

Peking University

Status and phase: Not yet enrolling; Phase 2

Conditions: Colles' Fracture

Treatments: Drug: recombinant teriparatide for injection; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04473989

M2020207

Details and patient eligibility

About

The purpose of this study is to examine the effect of weekly dosing strategy on fracture healing.

Enrollment: 80 estimated patients

Sex: Female

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Postmenopausal women aged 45-75 (at least 2 years after menopause)
2. With primary osteoporosis
3. Patients with Colles fractures with a fracture time of no more than 7 days
4. conservative treatment after fracture (closed reduction and immobilization)
5. no multiple fractures
6. Informed well and agree to participate in this clinical trial

Exclusion criteria

1. Combine other physical diseases, including diabetes, severe hypertension, autoimmune diseases, heart, liver and kidney diseases, malignant tumors, mental illnesses, and other diseases that doctors believe may affect the healing process.
2. In addition to primary osteoporosis, any disease affecting bone metabolism or treatment response, including serum PTH>65pg/ml, 25-hydroxyvitamin D<20ng/ml, alkaline phosphatase>135U/L, history of bone tumor, Paget disease, history of radiotherapy
3. The fracture site has a history of trauma or surgery, affecting the function of the wrist or forearm
4. Those who are allergic to PTH or any excipients
5. Currently receiving anti-osteoporosis treatment or receiving other anti-osteoporosis treatment during the trial
6. Contraindication of teriparatide including hyperparathyroidism, severe renal insufficiency, hypercalcemia, etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Injection product without active teriparatide

Treatment:

Drug: Placebo

PTH 40ug/w

Experimental group

Description:

Injection product with active teriparatide

Treatment:

Drug: recombinant teriparatide for injection