Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

NCT03158246 | Unknown Phase 4 DMC

• 1 other identifier: Cttq-POWER
• Study Type: interventional
• Target: 466
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoporosis, Postmenopausal

Keywords

zoledronic acid; Yigu; Aclasta; Osteoporosis; Postmenopausal; BMD; fracture; Biochemical markers

Outcome Measures

Primary Outcomes (1)

• Change in BMD T-scores

  BMD T-scores (spine, hip and femoral neck) are determined versus baseline at the visits time

  12 months

Secondary Outcomes (3)

• Change in BMD T-scores

  6 months

• Change in Biochemical markers of bone turnover

  14 days, 6 months and 12 months

• Fractures

  12 months

Study Arms (2)

Yigu Group

EXPERIMENTAL

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; Dietary Supplement: calcium; Dietary Supplement: vitamin D

Aclasta Group

ACTIVE COMPARATOR

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; Dietary Supplement: calcium; Dietary Supplement: vitamin D

Interventions

Generic Zoledronic Acid DRUG

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

Also known as: Yigu

Yigu Group

Original Zoledronic Acid DRUG

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

Also known as: Aclasta

Aclasta Group

calcium DIETARY_SUPPLEMENT

600mg/d calcium for oral daily

Aclasta Group; Yigu Group

vitamin D DIETARY_SUPPLEMENT

925IU/d vitamin D for oral daily

Aclasta Group; Yigu Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cttq: lead

Related Publications (1)

• 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.

  PMID: 39223504 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis; Fractures, Bone

Interventions

Zoledronic Acid; Calcium; Vitamin D

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Xia Weibo

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Li Mei

CONTACT

+86 13671312468; limeilzh@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: June 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: March 2, 2020
• Last Updated: May 23, 2017

Record last verified: 2017-05