A Randomized, Double-blinded, Active-controlled, Multicentered Phase III Trial to Assess the Efficacy and Safety of Minodronate Tablets in Postmenopausal Women With Osteoporosis

Shandong New Time Pharmaceutical Co., LTD1 site in 1 country330 target enrollmentMay 31, 2022

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

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

Overview

Phase: Phase 3
Intervention: Minodronate Tablets and Alendronate Sodium Tablets-matching placebo;Alendronate Sodium Tablets and Minodronate Tablets -matching placebo
Conditions: Osteoporosis
Sponsor: Shandong New Time Pharmaceutical Co., LTD
Enrollment: 330
Locations: 1
Primary Endpoint: 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.
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 31, 2022

End Date

May 31, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Shandong New Time Pharmaceutical Co., LTD

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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 ;

Arms & Interventions

Minodronate Tablets and Alendronate Sodium Tablets-matching placebo

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

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

Alendronate Sodium Tablets and Minodronate Tablets -matching placebo

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

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

Outcomes

Primary Outcomes

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.

Time Frame: 48 weeks

Secondary Outcomes

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)