A Phase III Clinical Study of Minodronate Tablets in Postmenopausal Women With Osteoporosis

NCT05305183 | Unknown Phase 3

• 1 other identifier: NTP-MNLS-T-Ⅲ
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

In the randomized, active-controlled, double-blinded, multicenter study, the efficacy and safety of monthly oral minodronate were examined and compared to that of weekly oral alendronate.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• The average rate of bone mineral density change of lumbar spine (L1-L4 ) was compared between 48 weeks after administration and before administration .the group of minodronate were examined and compared to that of alendronate.

  48 weeks

Secondary Outcomes (3)

• The average rate of bone mineral density change of lumbar spine (L1-L4 ) was compared between 24 weeks after administration and before administration .

  24weeks

• The change rate of bone turnover markers from baseline to 12、24、48 weeks, including serum type I collagen amino terminal peptide(P1NP) and serum C-terminal telopeptide of type 1 collagen (S-CTX ).

  12、24、48 weeks,

• the change rates of bone density at the femoral neck and the whole hip from baseline to the end of 24 and 48 weeks.

  24、48 weeks

Study Arms (2)

Alendronate Sodium Tablets and Minodronate Tablets -matching placebo

ACTIVE COMPARATOR

subjects received 70 mg alendronate sodium tablet weekly and a minodronate tablet matching placebo monthly for 48 weeks.

Drug: Minodronate Tablets and Alendronate Sodium Tablets-matching placebo;Alendronate Sodium Tablets and Minodronate Tablets -matching placebo

Minodronate Tablets and Alendronate Sodium Tablets-matching placebo

EXPERIMENTAL

subjects received 50mg minodronate tablets monthly and an alendronate sodium tablets -matching placebo weekly for 48 weeks.

Drug: Minodronate Tablets and Alendronate Sodium Tablets-matching placebo;Alendronate Sodium Tablets and Minodronate Tablets -matching placebo

Interventions

Minodronate Tablets and Alendronate Sodium Tablets-matching placebo;Alendronate Sodium Tablets and Minodronate Tablets -matching placebo DRUG

all subjects will receive Calcium Carbonate and Vitamin D3 Tablets as basic medication.

Alendronate Sodium Tablets and Minodronate Tablets -matching placebo; Minodronate Tablets and Alendronate Sodium Tablets-matching placebo

Eligibility Criteria

• Age: 46 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 46-80 years, menopause for more than 1 year, free to move，Estradiol ≤20pg/mL and follicle stimulating hormone ≥40IU/L in patients with simple hysterectomy;
• Body mass index (BMI) is 18.5-30.0kg/m2, including critical value, BMI= weight (kg)/height 2 (m2);
• Based on dual energy X-ray absorption (DXA)Determination, bone density (BMD) determination of lumbar vertebrae L1-L4 (At least 2 consecutive lumbar vertebrae for accurate measurement of BMD ) mean T ≤ -2.5SD, or T≤ -2.5SD on either side of the double hip femoral neck;
• Understand the procedures and methods of this clinical study, voluntarily participate in and sign the informed consent form.

You may not qualify if:

• Patients with conditions that affect BMD measurement, such as severe scoliosis or any lumbar L1-L4 fracture or hip fracture;
• Patients with secondary osteoporosis;
• Endocrine diseases or other diseases affecting bone metabolism that the investigator considers inappropriate, such as gonads, adrenal glands, primary parathyroid dysfunction, or malformed osteitis (Paget's bone disease), nephrotic rickets, osteomalacia, rheumatoid arthritis, osteogenesis imperfecta , poorly controlled hyperthyroidism or hypothyroidism;
• Patients with serious primary diseases such as cardiovascular, cerebrovascular and hematopoietic system, and mental or nervous system diseases;
• Patients with abnormal blood calcium: serum calcium or serum calcium corrected by albumin ≤2.0mmol/L or ≥2.9mmol/L;
• Parathyroid hormone \> 1.5 times the upper limit of normal;
• Patients with severe gastrointestinal absorption dysfunction such as dysphagia, esophagitis, enteritis or peptic ulcer，crohn's disease and chronic pancreatitis;
• Patients with delayed obstruction of the esophagus, such as narrow or loose esophagus;
• patients has previous or co-existing malignancies (except skin basal cell carcinoma and carcinoma in situ of the cervix, which have been cured for more than 3 years);
• The patient who are deformed, disabled, unable to work or in a critical condition; which difficult to evaluate the effectiveness and safety of drugs accurately ;
• Patients with type 1 diabetes or type 2 diabetes with poor glycemic control and severe acute and chronic complications;
• Patients had received any other investigational drug/device treatment within 3 months prior to enrollment;
• Patients with renal insufficiency or severe renal impairment(Ccr\<35mL/min);
• Patients with abnormal liver function (ALT or AST≥2.0 times the upper limit of normal);
• Allergic constitution or allergic to study related drugs (calcium, vitamin D, minodronic acid or similar drugs);

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Study Sites (1)

Shandong New Time Pharmaceutical Co., LTD

Shandong, China

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

YM 529

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Zhang jian xiang

CONTACT

0539-8330397; jianxiangzhang@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: May 31, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2024
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CN (1)