Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture

NCT ID: NCT04473989

Last Updated: 2020-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-06-01

Brief Summary

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

Detailed Description

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Conditions

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Colles' Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo

Injection product without active teriparatide

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

weekly subcutaneous administration of 40 ug

PTH 40ug/w

Injection product with active teriparatide

Group Type EXPERIMENTAL

recombinant teriparatide for injection

Intervention Type DRUG

weekly subcutaneous administration of 40 ug

Interventions

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recombinant teriparatide for injection

weekly subcutaneous administration of 40 ug

Intervention Type DRUG

Placebo

weekly subcutaneous administration of 40 ug

Intervention Type DRUG

Other Intervention Names

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Xinfutai Xinfutai placebo

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chunli Song, M.D.; Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Central Contacts

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Junxiong Zhu, M.D.

Role: CONTACT

+86 18801238160

References

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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.

Reference Type BACKGROUND
PMID: 19594305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28244906 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28960481 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33795297 (View on PubMed)

Other Identifiers

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M2020207

Identifier Type: -

Identifier Source: org_study_id

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