MedTrace Logo

Efficacy and Safety of Minodronate in Patients With Low Back Pain

NCT05645289 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-12-09

No results posted yet for this study

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.

Conditions

  • Postmenopausal Osteoporosis

Interventions

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.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Chunli Song, Pro. · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
95 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-12-31
Completion
2024-04-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05645289 on ClinicalTrials.gov