Efficacy and Safety of Minodronate in Patients With Low Back Pain
NCT ID: NCT05645289
Last Updated: 2022-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
72 participants
INTERVENTIONAL
2023-01-01
2024-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
minodronate
Patients will take 1 mg of minodronate tablets orally in the morning.
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.
alendronate
Patients will be orally given 10 mg alendronate tablets daily in the morning.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients with low back pain of at least 3 months and a VAS score ≥30;
3. The value of lumbar L1-4 or total hip bone density measured by DXA is \< -2.5;
4. Serum 25-hydroxyvitamin D (25-OHD) concentration ≥20 ng/mL;
5. Patients with full capacity for civil conduct and understanding of the research process and methods voluntarily participated in this study and signed the informed consent form.
Exclusion Criteria
2. Patients with a diagnosis of secondary OP;
3. The following drugs affecting bone metabolism were used before the screening:
Received injections of bisphosphonate and denosumab within 3 years; Received oral bisphosphonate, parathyroid hormones or analogues, strontium, or fluoride within 6 months; Received glucocorticoids, steroids, immunosuppressants, calcitonin, calcitriol or its analogues, thiazide diuretics, and ng-acting oestrogen/progesterone replacement therapy within 3 months;
4. Patients with a diagnosis of diseases affecting bone metabolism (e.g., osteogenesis imperfecta, malignancy, progressive diaphyseal dysplasia, Paget's disease, rheumatoid arthritis, osteosclerosis, osteoporosis with a slipped disc and spinal stenosis, and liver and kidney failure);
5. Patients are participating or have participated in an investigational drug study within 3 months before signing the informed consent form;
6. Patients under 75 years old with a creatinine clearance rate \< 60 mL/min and those \> 75 years old with a creatinine clearance rate \< 45 mL/min;
7. Serum calcium levels \< 2.0 mmol/L (8 mg/dL) or \> 2.7 mmol/L (11.0 mg/dL);
8. Patients with fever, severe infection, severe trauma, or major surgery within 30 days;
9. Patients with a QTc interval of \> 480 ms;
10. Patients are undergoing or planning to undergo invasive dental treatment;
11. Smoking history in the past six months;
12. Patients with a history of alcohol abuse (\> 15 g of alcohol per day, equivalent to 350 mL of beer or 150 mL of wine, more than twice per week) and drug abuse;
13. Patients with a prior history of cerebral infarction, ischaemic or haemorrhagic stroke;
14. Patients with implants and/or fractures in the lumbar spine or hip that interfere with BMD testing;
15. Received pain relievers (e.g., nonsteroidal anti-inflammatory drugs, central analgesics) or life interventions to relieve pain within 1 week before screening;
55 Years
95 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University Third Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chunli Song, Pro.
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Huan Wang, Ms.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Yoshioka T, Okimoto N, Okamoto K, Sakai A. A comparative study of the effects of daily minodronate and weekly alendronate on upper gastrointestinal symptoms, bone resorption, and back pain in postmenopausal osteoporosis patients. J Bone Miner Metab. 2013 Mar;31(2):153-60. doi: 10.1007/s00774-012-0393-x. Epub 2012 Oct 19.
Wang H, Huang J, Tao L, Liu D, Song C. Efficacy and safety of minodronate in the treatment of postmenopausal osteoporosis with low back pain: a single-centre, randomized and open-label controlled trial. Trials. 2024 Aug 13;25(1):534. doi: 10.1186/s13063-024-08364-7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M2022465
Identifier Type: -
Identifier Source: org_study_id