OsteoporosisPhase 2NCT03183557
Efficacy of Zoledronic Acid in Osteoporosis
A Phase 2 study testing "Zoledronic acid", "Reclast®" and "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®" in people with Osteoporosis, run by Shinshu University at 1 site in Japan.
Trial summary
There has been no comparative data between Zoledronic acid and Zoledronic acid combined with active vitamin D in primary and secondary osteoporosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- "Zoledronic acid", "Reclast®" and "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 12 Oct 2017to 8 Jun 2025
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoporotic patients who want to take zoledronic acid
Who cannot join
- Patients who are allergic to zoledronic acid or vitamin D
- Patients who are pregnant or breast-feeding
- Patients who have not taken zoledronic acid for the last 2 years
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Yukio Nakamura
Matsumoto, Nagano, 3908621
Yukio Nakamura, MD, PhD, +81-263-37-2659, yxn14@aol.jp
Yukio Nakamura, MD, PhD
About this study
Official title: Examination of Bone Metabolism and Bone Mineral Density by Zoledronic Acid in Primary and Secondary Osteoporosis
There has been no comparative data between Zoledronic acid and Zoledronic acid combined with active vitamin D in primary and secondary osteoporosis.
- Conditions
- Osteoporosis
- Being tested
- "Zoledronic acid", "Reclast®", "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Zoledronic acid", "Reclast®"Drug
To examine the efficacy of zoledronic acid in osteoporosis
"Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"Drug
To examine the efficacy of zoledronic acid plus alfacalcidol in osteoporosis
| Study group | Role | What they receive |
|---|---|---|
| ZA alone | Active comparator | Not described Receives: Drug: "Zoledronic acid", "Reclast®" |
| ZA plus VD | Active comparator | Not described Receives: Drug: "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Measured: Change from Baseline Values at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start12 Oct 2017
- Primary completion8 Dec 2022 (estimated)
- Study completion8 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shinshu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukio Nakamura, Shinshu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183557
- Sponsor's protocol ID
- Zol2017
- Status last verified
- Sep 2021
- First submitted
- 5 Jun 2017
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Bone Metabolism and Bone Mineral Density by Zoledronic Acid in Primary and Secondary Osteoporosis
- ClinicalTrials.gov ID
- NCT03183557
- Acronym / sponsor ID
- Zol2017
- Conditions
- Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shinshu UniversityUniversity, hospital or other
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 8 Dec 2022 (estimated)
- Study completion
- 8 Jun 2025 (estimated)
- First posted
- 12 Jun 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.
There has been no comparative data between Zoledronic acid and Zoledronic acid combined with active vitamin D in primary and secondary osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZA alone | Active comparator | Drug: "Zoledronic acid", "Reclast®" |
| ZA plus VD | Active comparator | Drug: "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®" |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoporotic patients who want to take zoledronic acid
Key exclusion criteria (3 listed)
- Patients who are allergic to zoledronic acid or vitamin D
- Patients who are pregnant or breast-feeding
- Patients who have not taken zoledronic acid for the last 2 years
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 |
|---|---|---|
| "Zoledronic acid", "Reclast®"To examine the efficacy of zoledronic acid in osteoporosis | Drug | ZA alone |
| "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"To examine the efficacy of zoledronic acid plus alfacalcidol in osteoporosis | Drug | ZA plus VD |
Primary outcome
Bone mineral density
Time frame: Change from Baseline Values at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing "Zoledronic acid", "Reclast®" and "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®" in people with Osteoporosis, run by Shinshu University at 1 site in Japan.
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 1 inclusion and 3 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 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yukio Nakamura, MD, PhD (+81-263-37-2659, yxn14@aol.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: Change from Baseline Values at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2021.