Current partner codePEPTIDESDE
NCT04473989·Phase 2·INTERVENTIONAL

Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture

Status

Unknown

Phase

Phase 2

Enrollment

80

Locations

0

Results

Not posted

Publications

4

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

recombinant teriparatide for injection

weekly subcutaneous administration of 40 ug

DRUG

Placebo

weekly subcutaneous administration of 40 ug

Timeline

From registration to results.

  1. First posted

    Jul 16, 2020

  2. Study start

    Jun 1, 2021

  3. Primary completion

    Dec 1, 2023

  4. Study completion

    Jun 1, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Jul 16, 2020

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
45 Years
Maximum age
75 Years
Sex
FEMALE
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.

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

Primary links

Continue at the source.

Related trials

More studies on Teriparatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.