Effect of weekly teriparatide injections on osteoporotic fracture healing: protocol for a double-blind, randomised controlled trial

IntroductionBoth animal studies and clinical trials have shown that daily parathyroid hormone administration promotes bone fracture healing. We previously found that weekly injections of the recombinant human parathyroid hormone teriparatide at a dosage of 20 μg/kg promoted tibial fracture healing to the same extent as daily injections of teriparatide at a dosage of 10 μg/kg in a rodent model. However, the effect of weekly teriparatide administration on human fracture healing is unreported. This protocol describes a randomised controlled clinical trial designed to evaluate whether weekly administration of teriparatide accelerates fracture repair in humans.Methods and analysisThis single-centre, double-blind, randomised controlled trial will be conducted in Peking University Third Hospital. Eligible patients with Colles’ fracture incurred within 48 hours will be randomly divided into two groups (n=40 per group) that will receive 14 weekly subcutaneous injections of either saline or teriparatide (40 μg/week). The primary outcome will be the time taken to achieve radiographic healing, as assessed using the modified radiographic union scale for tibial fractures. The secondary outcomes will be functional assessments, including the self-administered Patient-Rated Wrist Evaluation questionnaire, grip strength and rate of fracture non-union.Ethics and disseminationEthical approval has been obtained from the Peking University Third Hospital Medical Science Research Ethics Committee (M2020207). The findings will be disseminated in peer-reviewed publications.Trial registration numberNCT04473989: protocol version: 1.

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Multimodal neuronavigation-guided precision bypass in adult ischaemic patients with moyamoya disease: study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-025566 ◽

2019 ◽

Vol 9 (3) ◽

pp. e025566

Author(s):

Junlin Lu ◽

Yahui Zhao ◽

Li Ma ◽

Yu Chen ◽

Mingtao Li ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Moyamoya Disease ◽

Study Protocol ◽

Ct Perfusion ◽

Controlled Trial ◽

Controlled Clinical Trial ◽

Bypass Group ◽

Peking University ◽

Disease Study ◽

Randomised Controlled

IntroductionRevascularisation surgery is an important treatment of moyamoya disease (MMD). Several general methods of revascularisation had been used: direct, indirect and combined techniques. However, there had been no reports about the criteria of recipient arteries selection in bypass surgery for MMD. Surgeons usually choose the recipient arteries by their own experiences. Their choices of the recipient arteries are various and may contribute the different outcome of patients. The purpose is to identify utility and efficacy of precision bypass guided by multimodal neuronavigation of MMD in a prospective randomised controlled trial.Method and analysisThis study is a prospective randomised controlled clinical trial. This study will enrol a total of 100 eligible patients. These eligible patients will be randomised to the empirical bypass group and the multimodal neuronavigation-guided precision bypass group in a 1:1 ratio. Patient baseline characteristics and MMD characteristics will be described. In the multimodal neuronavigation-guided group, the blood velocity and blood flow of the recipient arteries will be identified. Surgical complications and outcomes at pretreatment, post-treatment, at discharge and at 3 month, 6 month, 12 month and end of trial will be analysed with CT perfusion, MRI, digital subtraction angiography, modified Rankin Scale, National Institute of Health Stroke Scale and modified Barthel Scale. This trial will determine whether multimodal neuronavigation-guided precision bypass is superior to empirical bypass in patients with MMD and identify the safety and efficacy of multimodal neuronavigation-guided precision bypass.Ethics and disseminationThe study protocol and written informed consent were reviewed and approved by the Clinical Research Ethics Committee of Peking University International Hospital. Study findings will be disseminated in the printed media. The study started in August, 2018 and expected to be completed in December, 2020.Trial registration numberNCT03516851; Pre-results.

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