Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

Osteoporosis, Postmenopausal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03158246
• Other study ID #: Cttq-POWER
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 16, 2017
• Last updated: May 21, 2017
• Start date: June 1, 2017
• Est. completion date: March 2, 2020

Study information

• Verified date: May 2017
• Source: Cttq
• Contact: Li Mei
• Phone: +86 13671312468
• Email: limeilzh[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 466
• Est. completion date: March 2, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 46 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• Generic Zoledronic Acid
Generic Zoledronic Acid (Yigu®) 5mg/100ml injection
• Original Zoledronic Acid
Original Zoledronic Acid (Aclasta®) 5mg/100ml injection

Dietary Supplement:
• calcium
600mg/d calcium for oral daily
• vitamin D
925IU/d vitamin D for oral daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cttq

Outcome

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