OsteoporosisPhase 3NCT01522521
Study of AK156 in Primary Osteoporosis Patients
A Phase 3 study testing AK156 in people with Osteoporosis, run by Asahi Kasei Therapeutics Corporation at 20 sites in Japan.
Trial summary
The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese patients with primary osteoporosis. Read more about this study
- Who is it for?
- Ages 65 to 89 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- AK156
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 20 sitesJapan
- Study dates
- Feb 2012to Jan 2015
- Phase
- Phase 3
- 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 65 to 89 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients diagnosed with primary osteoporosis
- Patients who have vertebral fractures at the time of screening
Who cannot join
- Patients diagnosed with secondary osteoporosis
- Patients with a current uncontrolled medical disorder or other condition which makes the patient unsuitable for the study
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Study site
Bungo-ōno, Oita Prefecture
Study site
Chiba, Chiba
Study site
Fukuoka, Fukuoka
Study site
Inami-cho, Hyōgo
Study site
Kagoshima, Kagoshima-ken
Study site
Kikukawa, Shizuoka
Study site
Kumamoto, Kumamoto
Study site
Kure, Hiroshima
Study site
Matsumoto, Nagano
Study site
Miyazaki, Miyazaki
Study site
Morioka, Iwate
Study site
Oyama, Tochigi
Study site
Sapporo, Hokkaido
Study site
Sendai, Miyagi
Study site
Setagaya City, Tokyo
Study site
Shinagawa, Tokyo
Study site
Tokorozawa, Saitama
Study site
Tonami, Toyama
Study site
Tosu, Saga-ken
Study site
Yokohama, Kanagawa
About this study
Official title: Phase 3 Study of AK156 in Primary Osteoporosis Patients
The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese patients with primary osteoporosis.
- Conditions
- Osteoporosis
- Being tested
- AK156, Placebo
- Keywords
- AK156
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK156Drug
zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years
PlaceboDrug
placebo (i.v.)/year + daily calcium and vitamin D for 2 years
| Study group | Role | What they receive |
|---|---|---|
| 1. | Experimental | Not described Receives: Drug: AK156 |
| 2. | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
New vertebral fractures
Reduction in the incidence rate of new fragility vertebral fractures
Measured: 2 Years
Secondary outcomes (4)
Vertebral fractures (worsening and new)
The incidence rate of fragility vertebral fractures (worsening and new)
Measured: 2 Years
Clinical fractures
The incidence rate of Clinical fractures
Measured: 2 Years
Bone mineral density
The percent change from baseline in bone mineral density of lumbar spine and hip
Measured: 2 Years
Bone metabolic marker
The percent change from baseline in bone metabolic marker
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asahi Kasei Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asahi Kasei Pharma Corporation, Study director, Clinical Development Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522521
- Sponsor's protocol ID
- AK156 III-1
- Status last verified
- Oct 2015
- First submitted
- 27 Jan 2012
- Last updated
- 2 Oct 2015
- Results posted
- No
Publications
Shiraki M, Kuroda T, Takeuchi Y, Sugimoto T, Tanaka S, Suzuki H, Hiraishi K, Nakamura T. Acute Phase Reactions After Intravenous Infusion of Zoledronic Acid in Japanese Patients with Osteoporosis: Sub-analyses of the Phase III ZONE Study. Calcif Tissue Int. 2021 Dec;109(6):666-674. doi: 10.1007/s00223-021-00884-7. Epub 2021 Jul 10.
PubMed 34247263Taguchi A, Shiraki M, Tanaka S, Ohshige H, Nakamura T. Improved periodontal disease and prevention of tooth loss in osteoporosis patients receiving once-yearly zoledronic acid: a randomized clinical trial. Menopause. 2019 Nov;26(11):1277-1283. doi: 10.1097/GME.0000000000001393.
PubMed 31688575Nakamura T, Fukunaga M, Nakano T, Kishimoto H, Ito M, Hagino H, Sone T, Taguchi A, Tanaka S, Ohashi M, Ota Y, Shiraki M. Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis: two-year results from a randomized placebo-controlled double-blind study (ZOledroNate treatment in Efficacy to osteoporosis; ZONE study). Osteoporos Int. 2017 Jan;28(1):389-398. doi: 10.1007/s00198-016-3736-y. Epub 2016 Sep 8.
PubMed 27631091
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of AK156 in Primary Osteoporosis Patients
- ClinicalTrials.gov ID
- NCT01522521
- Acronym / sponsor ID
- AK156 III-1
- Conditions
- Osteoporosis
- Keywords
- AK156
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Asahi Kasei Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 31 Jan 2012 (estimated)
- 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.
The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese patients with primary osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. | Experimental | Drug: AK156 |
| 2. | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with primary osteoporosis
- Patients who have vertebral fractures at the time of screening
Key exclusion criteria (2 listed)
- Patients diagnosed with secondary osteoporosis
- Patients with a current uncontrolled medical disorder or other condition which makes the patient unsuitable for the study
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 |
|---|---|---|
| AK156zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years | Drug | 1. |
| Placeboplacebo (i.v.)/year + daily calcium and vitamin D for 2 years | Drug | 2. |
Primary outcome
New vertebral fractures
Time frame: 2 Years
Reduction in the incidence rate of new fragility vertebral fractures
4 secondary outcomes
Vertebral fractures (worsening and new)
Time frame: 2 Years
Clinical fractures
Time frame: 2 Years
Bone mineral density
Time frame: 2 Years
Bone metabolic marker
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
- Derived from this study: PubMed 34247263Shiraki M, Kuroda T, Takeuchi Y, Sugimoto T, Tanaka S, Suzuki H, Hiraishi K, Nakamura T. Acute Phase Reactions After Intravenous Infusion of Zoledronic Acid in Japanese Patients with Osteoporosis: Sub-analyses of the Phase III ZONE Study. Calcif Tissue Int. 2021 Dec;109(6):666-674. doi: 10.1007/s00223-021-00884-7. Epub 2021 Jul 10.
- Derived from this study: PubMed 31688575Taguchi A, Shiraki M, Tanaka S, Ohshige H, Nakamura T. Improved periodontal disease and prevention of tooth loss in osteoporosis patients receiving once-yearly zoledronic acid: a randomized clinical trial. Menopause. 2019 Nov;26(11):1277-1283. doi: 10.1097/GME.0000000000001393.
- Derived from this study: PubMed 27631091Nakamura T, Fukunaga M, Nakano T, Kishimoto H, Ito M, Hagino H, Sone T, Taguchi A, Tanaka S, Ohashi M, Ota Y, Shiraki M. Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis: two-year results from a randomized placebo-controlled double-blind study (ZOledroNate treatment in Efficacy to osteoporosis; ZONE study). Osteoporos Int. 2017 Jan;28(1):389-398. doi: 10.1007/s00198-016-3736-y. Epub 2016 Sep 8.
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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.
Asahi Kasei Pharma Corporation study director
Clinical Development Center
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AK156 in people with Osteoporosis, run by Asahi Kasei Therapeutics Corporation at 20 sites 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New vertebral fractures (time frame: 2 Years). 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 NCT01522521, which also lists 3 linked publications.
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 2 Oct 2015.