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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025865
Receipt No. R000029739
Scientific Title Effects of once-yearly injected zoledronic acid hydrate on bone mineral density in patients with primary osteoporosis after daily teriparatide treatment
Date of disclosure of the study information 2017/02/28
Last modified on 2017/03/12

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Basic information
Public title Effects of once-yearly injected zoledronic acid hydrate on bone mineral density in patients with primary osteoporosis after daily teriparatide treatment
Acronym Effects of zoledronate therapy in patients with primary osteoporosis after teriparatide treatment
Scientific Title Effects of once-yearly injected zoledronic acid hydrate on bone mineral density in patients with primary osteoporosis after daily teriparatide treatment
Scientific Title:Acronym Effects of zoledronate therapy in patients with primary osteoporosis after teriparatide treatment
Region
Japan

Condition
Condition Primary osteoporosis
Classification by specialty
Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Single zoledronic acid hydrate will be injected once a year to patients with primary osteoporosis after more than 12 months of daily teriparatide treatment. The purpose of this study is to evaluate effects, such as bone mineral density, bone metabolic markers, and new bone fracture, after 12 months of single zoledronic acid therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quantitative change of lumbar bone mineral density after 12 months
Key secondary outcomes 1) Quantitative change of lumbar bone mineral density after 6 months
2) Quantitative change of femoral bone mineral density, new vertebral body fracture incidence and guantitative change of bone metabolic markers after 6 and 12 months

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Single injection of once-yealy zoledronic acid hydrate(5mg) with daily eldecalcitol(0.75microgram) and Calcium L-apapartate(600mg) for 12 months
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
55 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1)Patients treaed by daily teriparatid treatment for more than 12 months
2)Patients who can take zoledronic acid hydrate within 8 weeks after last daily subcutaneous teriparatid injection
3)Age: more than 55 yaers-old when we get consent
4)Sex: Female
5)Out patients
6)Patients after receiving explanation upon participation in this study, on the thorough understanding, that document consent is obtained by the free will of the study in person
Key exclusion criteria 1)Anaphylaxis or any history of hypersensitivity to zoledronic acid and other kinds of bisphosnate
2)Serious renal dysfunction: creatinine clearance< 35ml/min
3) Serious heart disease, serious liver dysfunction, diabetes mellitus
4)Endocrine and metabolic disaease which may affect to the bone metabolism, and secondary osteoporosis(e.g. glucocorticoide-induced osteoporosis, rheumatoid arthiritis, immobilization osteoporosis)
5) Patients treated with medication which affect to the bone metabolism as follows,
i)Glucocorticosteroids(more than 5mg for over 3 months) except inhaler or nasal drugs
ii) Anticancer drugs
6) Patient of the hypocalcemia
7) A pregnant woman or the woman who might be pregnant
8)Patients who was diagnosed all of the L2, L3 and L4 vertebral fractures before zolendronate injection
9)Ptients who were jugged to be inadequate for this study by investigators
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Kaida
Organization Ainomemorial hospital
Division name Department of orthopeadic surgery
Zip code
Address 3838-1 Kou, Aino,Unzen city, Nagasaki prefecture, Japan
TEL 0957-36-0015
Email ei2kaida@ainomhop.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Nakamura
Organization Ainomemorial hospital
Division name Department of orthopeadic surgery
Zip code
Address 3838-1 Kou, Aino,Unzen city, Nagasaki prefecture, Japan
TEL 0957-36-0015
Homepage URL
Email tkyknkmr78@yahoo.co.jp

Sponsor
Institute Ainomemorial hospital
Institute
Department

Funding Source
Organization Ainomemorial hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 26 Day
Last modified on
2017 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029739

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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