Dataset Information

Effect of alendronate sodium plus vitamin D₃ tablets on knee joint structure and osteoarthritis pain: a multi-center, randomized, double-blind, placebo-controlled study protocol.

ABSTRACT:

Background

Osteoarthritis (OA) is a major cause of pain and disability worldwide. Despite the relatively high burden of the disease, the currently available non-surgical treatment options are directed towards symptomatic relief. Therefore, we propose the use of alendronate as a disease modifying agent to help slow and prevent OA. In addition, this study will utilize Whole-Organ Magnetic Resonance Imaging Score (WORMS) to evaluate the structural integrity of cartilage in the study population. High-quality evidence, limited to a few well-conducted randomized trials, highlights contradictory results on the effect of bisphosphonates on knee function and progression of OA. Therefore, a placebo-controlled, randomized trial is needed to evaluate the combined effect of alendronate and vit D on the structure of cartilage utilizing the WORMS score and its ability to treat knee pain in OA patients.

Methods

This multicenter, randomized, double-blinded, placebo-controlled study will evaluate the efficacy and safety of alendronate in early OA. Patients will undergo a 1:1 double-blinded randomization to receive a one-year course of either alendronate sodium vitamin D₃ or placebo. The primary outcome is to compare WORMS score of knee joint at 6 and 12 months between both groups. Secondary endpoints will include WORMS score at 24 months, knee pain, radiographic progression of OA, severity of OA, quality of life, and serum inflammatory biomarkers at different assessment timepoints. To detect a 2.2% difference in cartilage loss between both groups with power of 80%, a sample size of 60 (30 per group) is proposed.

Discussion

This trial will give helpful and high-quality evidence regarding the potential therapeutic role of alendronate sodium vitamin D3, as compared to placebo, in the management of patients with knee OA regarding its role on cartilage loss, radiographic progression of OA, severity of OA, knee pain, quality of life, and inflammatory biomarkers. If proven effective, this intervention would be a great option for providing beneficial outcomes with a reduced cost in this patient population.

Trial registration

This trial was registered on clinicaltrials.gov (registration number: NCT04739592 ).

SUBMITTER: Peng HM

PROVIDER: S-EPMC9205115 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

Effect of alendronate sodium plus vitamin D<sub>3</sub> tablets on knee joint structure and osteoarthritis pain: a multi-center, randomized, double-blind, placebo-controlled study protocol.

Peng Hui-Ming HM Weng Xi-Sheng XS Li Ye Y Feng Bin B Qian Wenwei W Cai Dao-Zhang DZ Zhao Chang C Yao Zhen-Jun ZJ Yang Yi Y Zhang Chi C Wan Shengcheng S

BMC musculoskeletal disorders 20220617 1

<h4>Background</h4>Osteoarthritis (OA) is a major cause of pain and disability worldwide. Despite the relatively high burden of the disease, the currently available non-surgical treatment options are directed towards symptomatic relief. Therefore, we propose the use of alendronate as a disease modifying agent to help slow and prevent OA. In addition, this study will utilize Whole-Organ Magnetic Resonance Imaging Score (WORMS) to evaluate the structural integrity of cartilage in the study populat ...[more]

PMID: 35715774

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Dataset Information

Effect of alendronate sodium plus vitamin D₃ tablets on knee joint structure and osteoarthritis pain: a multi-center, randomized, double-blind, placebo-controlled study protocol.

Background

Methods

Discussion

Trial registration

Publications

Effect of alendronate sodium plus vitamin D<sub>3</sub> tablets on knee joint structure and osteoarthritis pain: a multi-center, randomized, double-blind, placebo-controlled study protocol.

Similar Datasets

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Tweets

Dataset Information

Effect of alendronate sodium plus vitamin D3 tablets on knee joint structure and osteoarthritis pain: a multi-center, randomized, double-blind, placebo-controlled study protocol.

Background

Methods

Discussion

Trial registration

Publications

Effect of alendronate sodium plus vitamin D<sub>3</sub> tablets on knee joint structure and osteoarthritis pain: a multi-center, randomized, double-blind, placebo-controlled study protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Effect of alendronate sodium plus vitamin D₃ tablets on knee joint structure and osteoarthritis pain: a multi-center, randomized, double-blind, placebo-controlled study protocol.