NCT05645289

Efficacy and Safety of Minodronate in Patients With Low Back Pain

Efficacy and Safety of Minodronate in the Treatment of Postmenopausal Osteoporosis With Low Back Pain: a Single-centre and Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 55 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

This study will provide objective evidence for the efficiency and safety of minodronate in the treatment of postmenopausal osteoporosis with low back pain protocol. Furthermore, it will be helpful to evaluate the quantitative relationship between bone metabolic markers (BTM) and bone mineral density (BMD) in patients with osteoporosis under different ages.

Detailed description

The study is a randomized, parallel controlled clinical trial in Chinese postmenopausal OP patients receiving minodronate or alendronate. Minodronate will be administered once daily for 12 weeks, and alendronate will be administered once daily for 12 weeks. This study is divided into two stages: the first stage is 12 weeks, and at the end of the first stage, the results of patients' back pain and gastrointestinal adverse reactions will be summarized; the second stage is 12 weeks, and the pharmacokinetic and pharmacodynamic characteristics of patients will be summarized at the end of the second stage. The VAS score in this study rangs from 0-100 mm. During the screening, the patient's past pain relief methods, such as pain medication or the way of life intervention will be recorded. The use of the above methods during the patients' treatment will be prohibited to prevent interference with the results of the clinical trials. During the treatment, if patients experience sudden aggravation of low back pain, the VAS score is more than 70, and the patients could not bear the pain, a rescue drug (acetaminophen) will be used uniformly to relieve the pain. Throughout the trial, a total of 5 follow-up visits will be planned. The VAS score, PK\&PD sampling, BMD evaluation, and Izumo scale score will be calculated.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Minodronate	The minodronate group: The group will include thirty-six patients. Patients will take 1 mg of minodronate tablets orally with 200 mL of water in the morning. They can not lie flat for at least 30 minutes after taking the tablets, and they can not eat anything except water for at least 30 minutes after taking the tablets once a day for 12 weeks, for a total of 84 times.
DRUG	Alendronate	The alendronate group: A total of 36 patients will be treated with alendronate. Patients will be orally given 10-mg alendronate tablets daily and 200 mL of water in the morning. They could not lie down and eat anything except water for at least 30 minutes after taking the tablets. The treatment lasted for 12 weeks, corresponding to a total of 84 doses.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-12-31
• Completion: 2024-04-01
• First posted: 2022-12-09
• Last updated: 2022-12-09

Locations

1 site across 1 country: China