Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture

Phase 2

• Conditions: Colles' Fracture
• Interventions: Drug: Placebo; Drug: recombinant teriparatide for injection

• Registration Number: NCT04473989
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-07-12
• Study First Submitted QC: 2020-07-12
• Last Update Submitted: 2020-07-12
• Study First Posted: 2020-07-16
• Last Update Posted: 2020-07-16
• Study Start: 2021-06-01
• Primary Completion: 2023-12-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Injection product without active teriparatide
PTH 40ug/w	recombinant teriparatide for injection	Injection product with active teriparatide

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient-Rated Wrist Evaluation	0, 4, 6, 8, 10, 12, 14 and 16 weeks	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).
Grip strength	6, 8, 10, 12, 14, and 16 weeks	Grip strength will be assessed by a dynamometer.