Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture

NCT04473989 | Unknown Phase 2

• 1 other identifier: M2020207
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Colles' Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient-Rated Wrist Evaluation

  0, 4, 6, 8, 10, 12, 14 and 16 weeks

• Grip strength

  6, 8, 10, 12, 14, and 16 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Injection product without active teriparatide

Drug: Placebo

PTH 40ug/w

EXPERIMENTAL

Injection product with active teriparatide

Drug: recombinant teriparatide for injection

Interventions

recombinant teriparatide for injection DRUG

weekly subcutaneous administration of 40 ug

Also known as: Xinfutai

PTH 40ug/w

Placebo DRUG

weekly subcutaneous administration of 40 ug

Also known as: Xinfutai placebo

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Postmenopausal women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Related Publications (4)

• Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731.

  PMID: 19594305 BACKGROUND

• Ebata S, Takahashi J, Hasegawa T, Mukaiyama K, Isogai Y, Ohba T, Shibata Y, Ojima T, Yamagata Z, Matsuyama Y, Haro H. Role of Weekly Teriparatide Administration in Osseous Union Enhancement within Six Months After Posterior or Transforaminal Lumbar Interbody Fusion for Osteoporosis-Associated Lumbar Degenerative Disorders: A Multicenter, Prospective Randomized Study. J Bone Joint Surg Am. 2017 Mar 1;99(5):365-372. doi: 10.2106/JBJS.16.00230.

  PMID: 28244906 BACKGROUND

• Zhang W, Zhu J, Ma T, Liu C, Hai B, Du G, Wang H, Li N, Leng H, Xu Y, Song C. Comparison of the effects of once-weekly and once-daily rhPTH (1-34) injections on promoting fracture healing in rodents. J Orthop Res. 2018 Apr;36(4):1145-1152. doi: 10.1002/jor.23750. Epub 2017 Nov 20.

  PMID: 28960481 BACKGROUND

• Zhu J, Zhang C, Jia J, Yuan W, Zhang M, Leng H, Song C. Effect of weekly teriparatide injections on osteoporotic fracture healing: protocol for a double-blind, randomised controlled trial. BMJ Open. 2021 Apr 1;11(4):e043137. doi: 10.1136/bmjopen-2020-043137.

  PMID: 33795297 DERIVED

MeSH Terms

Conditions

Colles' Fracture

Interventions

Injections

Condition Hierarchy (Ancestors)

Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Radius Fractures; Fractures, Bone

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Chunli Song, M.D.; Ph. D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junxiong Zhu, M.D.

CONTACT

+86 18801238160; zhujunxiong@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 16, 2020
• Study Start: June 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: July 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share