Osteoporosis, PostmenopausalPhase 4NCT03158246
Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women
A Phase 4 study testing Generic Zoledronic Acid, Original Zoledronic Acid and calcium in people with Osteoporosis, Postmenopausal, run by Cttq.
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. Read more about this study
- Who is it for?
- Ages 46 to 80 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Generic Zoledronic Acid, Original Zoledronic Acid and calcium
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 2 Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Generic Zoledronic Acid Versus Original Zoledronic Acid: A Multicenter, Randomized, Open, Paralled-controlled Clinical Postmenopausal Osteoporotic Women Efficacy and Safety Research.
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.
Read the 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
- Being tested
- Generic Zoledronic Acid, Original Zoledronic Acid, calcium, vitamin D
- Keywords
- zoledronic acid, Yigu, Aclasta, Osteoporosis, Postmenopausal, BMD, fracture, Biochemical markers
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic Zoledronic AcidDrug
Also called Yigu
Generic Zoledronic Acid (Yigu®) 5mg/100ml injection
Original Zoledronic AcidDrug
Also called Aclasta
Original Zoledronic Acid (Aclasta®) 5mg/100ml injection
calciumDietary supplement
600mg/d calcium for oral daily
vitamin DDietary supplement
925IU/d vitamin D for oral daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Original Zoledronic Acid; Dietary Supplement: calcium; Dietary Supplement: vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMD T-scores
BMD T-scores (spine, hip and femoral neck) are determined versus baseline at the visits time
Measured: 12 months
Secondary outcomes (3)
Change in BMD T-scores
BMD T-scores (spine, hip and femoral neck) are determined versus baseline at the visits time
Measured: 6 months
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
Measured: 14 days, 6 months and 12 months
Fractures
incidence of fracture of all parts
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion2 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cttq
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xia Weibo, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158246
- Sponsor's protocol ID
- Cttq-POWER
- Status last verified
- May 2017
- First submitted
- 16 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39223504
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generic Zoledronic Acid Versus Original Zoledronic Acid: A Multicenter, Randomized, Open, Paralled-controlled Clinical Postmenopausal Osteoporotic Women Efficacy and Safety Research.
- ClinicalTrials.gov ID
- NCT03158246
- Acronym / sponsor ID
- Cttq-POWER
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- zoledronic acid, Yigu, Aclasta, Osteoporosis, Postmenopausal, BMD, fracture, Biochemical markers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- CttqIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 2 Mar 2020 (estimated)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yigu Group | Experimental | Drug: Generic Zoledronic Acid, Dietary Supplement: calcium, Dietary Supplement: vitamin Da 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 |
| Aclasta Group | Active comparator | Drug: Original Zoledronic Acid, Dietary Supplement: calcium, Dietary Supplement: vitamin Da 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 |
Who may qualify
- Ages
- 46 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Generic Zoledronic AcidAlso: YiguGeneric Zoledronic Acid (Yigu®) 5mg/100ml injection | Drug | Yigu Group |
| Original Zoledronic AcidAlso: AclastaOriginal Zoledronic Acid (Aclasta®) 5mg/100ml injection | Drug | Aclasta Group |
| calcium600mg/d calcium for oral daily | Dietary supplement | Aclasta Group, Yigu Group |
| vitamin D925IU/d vitamin D for oral daily | Dietary supplement | Aclasta Group, Yigu Group |
Primary outcome
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
3 secondary outcomes
Change in BMD T-scores
Time frame: 6 months
Change in Biochemical markers of bone turnover
Time frame: 14 days, 6 months and 12 months
Fractures
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Derived from this study: PubMed 39223504Du 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xia Weibo study chair
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Generic Zoledronic Acid, Original Zoledronic Acid and calcium in people with Osteoporosis, Postmenopausal, run by Cttq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Mei (+86 13671312468, limeilzh@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMD T-scores (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03158246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.