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Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03158246
Recruitment Status : Unknown
Verified May 2017 by Cttq.
Recruitment status was:  Not yet recruiting
First Posted : May 18, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Cttq

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.

Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Drug: Generic Zoledronic Acid Drug: Original Zoledronic Acid Dietary Supplement: calcium Dietary Supplement: vitamin D Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 466 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Generic Zoledronic Acid Versus Original Zoledronic Acid: A Multicenter, Randomized, Open, Paralled-controlled Clinical Postmenopausal Osteoporotic Women Efficacy and Safety Research.
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 2, 2020

Resource links provided by the National Library of Medicine


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 Name: 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

Drug: Original Zoledronic Acid
Original Zoledronic Acid (Aclasta®) 5mg/100ml injection
Other Name: Aclasta

Dietary Supplement: calcium
600mg/d calcium for oral daily

Dietary Supplement: vitamin D
925IU/d vitamin D for oral daily




Primary Outcome Measures :
  1. Change in BMD T-scores [ Time Frame: 12 months ]
    BMD T-scores (spine, hip and femoral neck) are determined versus baseline at the visits time


Secondary Outcome Measures :
  1. Change in BMD T-scores [ Time Frame: 6 months ]
    BMD T-scores (spine, hip and femoral neck) are determined versus baseline at the visits time

  2. Change in Biochemical markers of bone turnover [ Time Frame: 14 days, 6 months and 12 months ]
    Biochemical markers of bone turnover are determined versus baseline at the visits time. Including β-CTX and P1NP

  3. Fractures [ Time Frame: 12 months ]
    incidence of fracture of all parts



Information from the National Library of Medicine

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Ages Eligible for Study:   46 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158246


Contacts
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Contact: Li Mei +86 13671312468 limeilzh@sina.com

Sponsors and Collaborators
Cttq
Investigators
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Study Chair: Xia Weibo Peking Union Medical College Hospital
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Responsible Party: Cttq
ClinicalTrials.gov Identifier: NCT03158246    
Other Study ID Numbers: Cttq-POWER
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cttq:
zoledronic acid
Yigu
Aclasta
Osteoporosis
Postmenopausal
BMD
fracture
Biochemical markers
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Zoledronic Acid
Calcium
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents