Efficacy and Safety of Minodronate in Patients With Low Back Pain

NCT05645289 | Unknown Phase 4

• 1 other identifier: M2022465
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

minodronate; low back pain; adverse reactions; pharmacokinetic; pharmacodynamic

Outcome Measures

Primary Outcomes (1)

• The time for a 10 point decrease in the VAS score within 24 weeks

  The VAS scores were measured daily within 24 weeks. Back pain was evaluated using a 100-mm VAS score ( 0 = no pain, 100 = worst pain possible) after treatment, where the patients recorded their pain on the VAS by themselves everyday.

  up to 24 weeks

Secondary Outcomes (11)

• Concentration in plasma of minodronate and alendronate on the first day before administration

  on the first day before administration

• Concentration in plasma of minodronate and alendronate on the 8th week after administration

  on the 8th week after administration

• Concentration in plasma of minodronate and alendronate on the 12th week after administration

  on the 12th week after administration

• Concentration in plasma of minodronate and alendronate on the 24th week after administration

  on the 24th week after administration

• Maximum concentration of minodronate and alendronate within 24 weeks

  0-24 weeks

Study Arms (2)

minodronate

EXPERIMENTAL

Patients will take 1 mg of minodronate tablets orally in the morning.

Drug: Minodronate

alendronate

ACTIVE COMPARATOR

Patients will be orally given 10 mg alendronate tablets daily in the morning.

Drug: Alendronate

Interventions

Minodronate DRUG

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.

Also known as: Difumi

minodronate

Alendronate DRUG

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.

Also known as: Fushanmei

alendronate

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese postmenopausal patients with a diagnosis of OP;
• Patients with low back pain of at least 3 months and a VAS score ≥30;
• The value of lumbar L1-4 or total hip bone density measured by DXA is \< -2.5;
• Serum 25-hydroxyvitamin D (25-OHD) concentration ≥20 ng/mL;
• 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.

You may not qualify if:

• Patient who are allergic to minodronate, alendronate, or other bisphosphonate drug or any other component of the drug under evaluation;
• Patients with a diagnosis of secondary OP;
• 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;
• 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);
• Patients are participating or have participated in an investigational drug study within 3 months before signing the informed consent form;
• 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;
• Serum calcium levels \< 2.0 mmol/L (8 mg/dL) or \> 2.7 mmol/L (11.0 mg/dL);
• Patients with fever, severe infection, severe trauma, or major surgery within 30 days;
• Patients with a QTc interval of \> 480 ms;
• Patients are undergoing or planning to undergo invasive dental treatment;
• Smoking history in the past six months;
• 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;
• Patients with a prior history of cerebral infarction, ischaemic or haemorrhagic stroke;
• Patients with implants and/or fractures in the lumbar spine or hip that interfere with BMD testing;

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (2)

• 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.

  PMID: 23076293 BACKGROUND

• 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.

  PMID: 39135126 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Low Back Pain

Interventions

YM 529; Alendronate

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Chunli Song, Pro.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huan Wang, Ms.

CONTACT

18251825313; wh18324178960@163.com

Chunli Song, Pro.

CONTACT

schl@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 9, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: April 1, 2024
• Last Updated: December 9, 2022

Record last verified: 2022-11

Locations

CN (1)