Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effect of weekly dosing strategy on fracture healing.

Official Title
-----------------
The Effect of Weekly Injection of Teriparatide on the Healing of Distal Radius Fracture in a Double-blind, Randomized Controlled Clinical Trial

Conditions
-----------------
Colles' Fracture

Intervention / Treatment
-----------------
* Drug: recombinant teriparatide for injection
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women aged 45-75 (at least 2 years after menopause) With primary osteoporosis Patients with Colles fractures with a fracture time of no more than 7 days conservative treatment after fracture (closed reduction and immobilization) no multiple fractures Informed well and agree to participate in this clinical trial Exclusion Criteria: 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. 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 The fracture site has a history of trauma or surgery, affecting the function of the wrist or forearm Those who are allergic to PTH or any excipients Currently receiving anti-osteoporosis treatment or receiving other anti-osteoporosis treatment during the trial Contraindication of teriparatide including hyperparathyroidism, severe renal insufficiency, hypercalcemia, etc.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Injection product without active teriparatide | Drug: Placebo<br>* weekly subcutaneous administration of 40 ug<br>* Other names: Xinfutai placebo;|
| Experimental: PTH 40ug/w<br>Injection product with active teriparatide | Drug: recombinant teriparatide for injection<br>* weekly subcutaneous administration of 40 ug<br>* Other names: Xinfutai;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The median time of radiographic healing | A score of 13 by Modified Radiographic Union Scale for Tibia fractures (mRUST) scoring system would provide a confident assessment of union | 0-14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Rated Wrist Evaluation | A 15-item questionnaire(PRWE) that rates wrist-related pain and disability in functional activities. The scores range from 0 (no disability) to 100 (severest disability). | 0, 4, 6, 8, 10, 12, 14 and 16 weeks | 
| Grip strength | Grip strength will be assessed by a dynamometer. | 6, 8, 10, 12, 14, and 16 weeks |