Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

Sponsor

Cttq (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03158246

Collaborator

(none)

466

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study compares the efficacy and safety of generic zoledronic acid (Yigu®) and original zoledronic acid (Aclasta®) in the treatment of postmenopausal osteoporotic women in China. Four hundred and sixty-six subjects will be randomised (1:1ratio) to either Yigu® 5mg IV or Aclasta® 5mg IV treatment arms.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis, Postmenopausal	Drug: Generic Zoledronic Acid Drug: Original Zoledronic Acid Dietary Supplement: calcium Dietary Supplement: vitamin D	Phase 4

Detailed Description

A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis, and it significantly reduced the risk of vertebral fractures additionally.

In this research, the efficacy and safety of generic zoledronic acid injection in the treatment of postmenopausal osteoporosis will be evaluated, using original drug as control drug. It will provide evidence for reasonable clinical administrations.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

466 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Generic Zoledronic Acid Versus Original Zoledronic Acid: A Multicenter, Randomized, Open, Paralled-controlled Clinical Postmenopausal Osteoporotic Women Efficacy and Safety Research.

Anticipated Study Start Date :

Jun 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Mar 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Yigu Group a single 15-minute infusion of Generic Zoledronic Acid (Yigu®) (5 mg/100ml) 600mg/d calcium and 925IU/d vitamin D for oral daily, 12 months	Drug: Generic Zoledronic Acid Generic Zoledronic Acid (Yigu®) 5mg/100ml injection Other Names: Yigu Dietary Supplement: calcium 600mg/d calcium for oral daily Dietary Supplement: vitamin D 925IU/d vitamin D for oral daily
Active Comparator: Aclasta Group a single 15-minute infusion of Original Zoledronic Acid (Aclasta®) (5 mg/100ml) 600mg/d calcium and 925IU/d vitamin D for oral daily, 12 months	Drug: Original Zoledronic Acid Original Zoledronic Acid (Aclasta®) 5mg/100ml injection Other Names: Aclasta Dietary Supplement: calcium 600mg/d calcium for oral daily Dietary Supplement: vitamin D 925IU/d vitamin D for oral daily

Arm

Intervention/Treatment

Experimental: Yigu Group

a single 15-minute infusion of Generic Zoledronic Acid (Yigu®) (5 mg/100ml) 600mg/d calcium and 925IU/d vitamin D for oral daily, 12 months

Drug: Generic Zoledronic Acid

Generic Zoledronic Acid (Yigu®) 5mg/100ml injection

Other Names:

Yigu

Dietary Supplement: calcium

600mg/d calcium for oral daily

Dietary Supplement: vitamin D

925IU/d vitamin D for oral daily

Active Comparator: Aclasta Group

a single 15-minute infusion of Original Zoledronic Acid (Aclasta®) (5 mg/100ml) 600mg/d calcium and 925IU/d vitamin D for oral daily, 12 months

Drug: Original Zoledronic Acid

Original Zoledronic Acid (Aclasta®) 5mg/100ml injection

Other Names:

Aclasta

Dietary Supplement: calcium

600mg/d calcium for oral daily

Dietary Supplement: vitamin D

925IU/d vitamin D for oral daily

Outcome Measures

Primary Outcome Measures

Change in BMD T-scores [12 months]
BMD T-scores (spine, hip and femoral neck) are determined versus baseline at the visits time

Secondary Outcome Measures

Change in BMD T-scores [6 months]
BMD T-scores (spine, hip and femoral neck) are determined versus baseline at the visits time
Change in Biochemical markers of bone turnover [14 days, 6 months and 12 months]
Biochemical markers of bone turnover are determined versus baseline at the visits time. Including β-CTX and P1NP
Fractures [12 months]
incidence of fracture of all parts

Eligibility Criteria

Criteria

Ages Eligible for Study:

46 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Postmenopausal women between the ages of 46 and 80（cessation of menses for 12 months for any reason）
Subjects with osteoporosis diagnosed according to the World Health Organization (WHO) criteria：they had a BMD T-score of -2.5 or less at the spine or femoral neck；or they had low bone mass，defined as BMD T-score less than -1.0 and more than -2.5 at the spine or femoral neck，with the history of fragility fracture(Fracture site included vertebra, hip,proximal humera, distal radius, distal ulna)
Subjects signed informed consent voluntarily

Exclusion Criteria:

Any non-primary osteoporosis skeletal disease
Subjects with abnormal hepatic function and renal function（alanine transaminase(ALT) and aspartate transaminase(AST) are 2 times higher than the upper limits of normal(ULN);plasma creatinine concentration and blood urea nitrogen are more than 1.5 ULN or calculated creatinine clearance less than 60 ml/min）
Subjects with serum calcium greater than 2.75 mmol/L (11.0 mg/dL) or less than 2.00 mmol/L (8.0 mg/dL)
Subjects with severe heart disease, blood disease, mental diseases
Subjects with cancer and other serious progressive disease
Prior therapy with bisphosphonates within 12 months before trial entry, prior therapy with parathyroid hormone 1-34 or 1-84, estrogen, selective estrogen receptor modulators, strontium more than 2 weeks within 6 months, prior therapy with oral or intravenous glucocorticoid more than 3 months within 6 months
Subject is hypersensitivity to experimental drugs, comparator drugs and their metabolites
Subjects who participated in other drugs or medical devices clinical studies as subjects within 3 months before this study
Subjects judged unfit for this study by investigators