Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoporosis, Postmenopausal
• Intervention / Treatment: Drug: Generic Zoledronic Acid; Dietary supplement: calcium; Dietary supplement: vitamin D; Drug: Original Zoledronic Acid

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 Type: Interventional
• Enrollment (Anticipated): 466
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Li Mei; Phone Number: +86 13671312468; Email: limeilzh@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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	Dietary supplement: calcium; 600mg/d calcium for oral daily; Dietary supplement: vitamin D; 925IU/d vitamin D for oral daily; Drug: Original Zoledronic Acid; Original Zoledronic Acid (Aclasta®) 5mg/100ml injection; Other Names: Aclasta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMD T-scores	BMD T-scores (spine, hip and femoral neck) are determined versus baseline at the visits time	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cttq
• Investigators: Study Chair: Xia Weibo, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2017
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): March 2, 2020

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (ACTUAL): May 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 21, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: fracture; Osteoporosis; Postmenopausal; BMD; zoledronic acid; Biochemical markers; Aclasta; Yigu
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium; Zoledronic Acid
• Other Study ID Numbers: Cttq-POWER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No