DRUG
recombinant teriparatide for injection
weekly subcutaneous administration of 40 ug
Status
Unknown
Phase
Phase 2
Enrollment
80
Locations
0
Results
Not posted
Publications
4
Study summary
The purpose of this study is to examine the effect of weekly dosing strategy on fracture healing.
Interventions
DRUG
weekly subcutaneous administration of 40 ug
DRUG
weekly subcutaneous administration of 40 ug
Timeline
First posted
Jul 16, 2020
Study start
Jun 1, 2021
Primary completion
Dec 1, 2023
Study completion
Jun 1, 2024
Results posted
Not reported
Registry updated
Jul 16, 2020
Outcomes
The median time of radiographic healing
Time frame · 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
Patient-Rated Wrist Evaluation
Time frame · 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
Time frame · 6, 8, 10, 12, 14, and 16 weeks
Grip strength will be assessed by a dynamometer.
Eligibility
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.
Study locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
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