Triple blind evaluation of the efficacy of oral calcium Hydroxy-apatite on post-operative pain, grip and bone mineral density after distal radius fracture surgery

Comparison of the effectiveness of oral calcium hydroxyapatite with calcium carbonate in patients after distal radius fracture fixation surgery

A randomized, triple-blinded, phase 3 clinical trial with a parallel-group design of 150 patients

All patients over 45 years of age referred to the trauma emergency department of Shariati Hospital with distal radius fractures who are candidates for surgery will be included in the study. Medication packages with the same appearance which randomly contain one of two calcium supplements will be assigned to patients admitted to the study. Thereby, the patient and the physician, and the data analyzer will not be informed of the drugs allocated.

All patients over 45 years of age referred to the trauma emergency department of Shariati Hospital with distal radius fractures who are candidates for surgery will be included in the study from April 2022 to April 2023. Patients who are not candidates for surgery due to medical problems with an ASA score of 3 or higher will be excluded from the study. Patients who have received osteoporosis treatments before surgery, including bisphosphonates, calcium and vitamin D supplements, or hormone therapy, will be excluded from the study.Patients with mental disorders who may not be able to cooperate in study will be excluded.

Patients are randomly divided into case and control groups after surgery. The control group will receive daily calcium carbonate , vitamin D and Alendronate in addition to the post-up protocol while the case group will receive oral calcium hydroxyapatite , vitamin D and Alendronate in addition to the post-up protocol.

-Bone density -Pain - Union of fracture -Grip force - Recurrence of fracture

150 drug packs containing vitamin D supplements, alendronate, and one of the two types of calcium carbonate or calcium hydroxyapatite supplements are prepared by the project sponsoring company with the same appearance and delivered to the researchers. The allocation of one of the two types of calcium supplements will be done in such a way that each type of supplement is present in 75 packages out of a total of 150 packages.Randomization will be done by randomizer.org software. Numbers from 1 to 150 will be arranged randomly. Based on the generated random sequence, each patient will be assigned a number in order of referral. (The first random sequence number to the first Patient, the second random sequence number to the second patient ...) Numbers 1 to 75 will be in the calcium hydroxyapatite group and numbers 76 to 150 will be in the calcium carbonate group. Thereby, the patient and the physician, and the data analyzer will not be informed of the drugs allocated. For confidence, there will be two additional copies of the decoded table of numbers and contents of the packages in the hand of researchers and data analyzers, which will not be opened until the end of the research.

150 packages of drugs containing tested drugs with the same appearance are prepared by the sponsoring company. Using simple randomization by computer software, one of the two types of calcium supplements is placed in each packet, and an ID is assigned to each packet. The coding table of IDs and its contents is prepared in a sealed envelope that will not be opened until the end of the study. In this way, the therapist and the patient and the data analyst will not be aware of the contents of the packages and the study will be conducted in a triple-blind manner.

All data is potentially shareable after anonymizing identifications.

After printing the results as an article

Researchers working in academic institutions

For further research purposes and analysis

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