Colles' Fracture
Conditions
Brief summary
The purpose of this study is to examine the effect of weekly dosing strategy on fracture healing.
Interventions
DRUGrecombinant teriparatide for injection
weekly subcutaneous administration of 40 ug
DRUGPlacebo
weekly subcutaneous administration of 40 ug
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactJunxiong Zhu, M.D.
Outcome results
None listed