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Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

Primary Purpose

Osteoporosis, Postmenopausal

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Generic Zoledronic Acid

Original Zoledronic Acid

calcium

vitamin D

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal focused on measuring zoledronic acid, Yigu, Aclasta, Osteoporosis, Postmenopausal, BMD, fracture, Biochemical markers

Eligibility Criteria

46 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yigu Group

Aclasta Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in BMD T-scores

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

Secondary Outcome Measures

Change in BMD T-scores

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

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

Fractures

incidence of fracture of all parts

Full Information

NCT ID

NCT03158246

First Posted

May 16, 2017

Last Updated

May 21, 2017

Sponsor

Cttq

1. Study Identification

Unique Protocol Identification Number

NCT03158246

Brief Title

Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2017 (Anticipated)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

March 2, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cttq

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Postmenopausal

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

466 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Yigu Group

Arm Type

Experimental

Arm Description

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

Arm Title

Aclasta Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Generic Zoledronic Acid

Other Intervention Name(s)

Yigu

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Original Zoledronic Acid

Other Intervention Name(s)

Aclasta

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

calcium

Intervention Description

600mg/d calcium for oral daily

Intervention Type

Dietary Supplement

Intervention Name(s)

vitamin D

Intervention Description

925IU/d vitamin D for oral daily

Primary Outcome Measure Information:

Title

Change in BMD T-scores

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change in BMD T-scores

Description

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

Time Frame

6 months

Title

Change in Biochemical markers of bone turnover

Description

Biochemical markers of bone turnover are determined versus baseline at the visits time. Including β-CTX and P1NP

Time Frame

14 days, 6 months and 12 months

Title

Fractures

Description

incidence of fracture of all parts

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

46 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Mei

Phone

+86 13671312468

limeilzh@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xia Weibo

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

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