Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

NCT ID: NCT03158246

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 466 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2020-03-02

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.

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.

Conditions

Osteoporosis, Postmenopausal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Generic Zoledronic Acid

Intervention Type: DRUG

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

calcium

Intervention Type: DIETARY_SUPPLEMENT

600mg/d calcium for oral daily

vitamin D

Intervention Type: DIETARY_SUPPLEMENT

925IU/d vitamin D for oral daily

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

Group Type: ACTIVE_COMPARATOR

Original Zoledronic Acid

Intervention Type: DRUG

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

calcium

Intervention Type: DIETARY_SUPPLEMENT

600mg/d calcium for oral daily

vitamin D

Intervention Type: DIETARY_SUPPLEMENT

925IU/d vitamin D for oral daily

Interventions

Generic Zoledronic Acid

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

Intervention Type: DRUG

Original Zoledronic Acid

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

Intervention Type: DRUG

calcium

600mg/d calcium for oral daily

Intervention Type: DIETARY_SUPPLEMENT

vitamin D

925IU/d vitamin D for oral daily

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Yigu; Aclasta

Eligibility Criteria

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

• Minimum Eligible Age: 46 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cttq

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xia Weibo

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Central Contacts

Li Mei

Role: CONTACT

limeilzh@sina.com

+86 13671312468

References

Du Y, Yu W, Gou H, Lei Y, Zhang T, Tang W, Chen M, Li H, Cheng Q. Change in body temperature, not acute-phase reaction, predict anti-Osteoporosis efficacy after the first administration of Zoledronic acid: a prospective observational cohort study. BMC Musculoskelet Disord. 2024 Sep 2;25(1):694. doi: 10.1186/s12891-024-07781-8.

Reference Type: DERIVED

PMID: 39223504 (View on PubMed)

Other Identifiers

Cttq-POWER

Identifier Type: -

Identifier Source: org_study_id