UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025865 |
|---|---|
| Receipt number | 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 10:38:41 |
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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
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
tkyknkmr78@yahoo.co.jp
Sponsor or person
Institute
Ainomemorial hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029739
