UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of once-yearly injected zoledronic acid hydrate on bone mineral density in patients with primary osteoporosis after daily teriparatide treatment
Title of the study (Brief title)	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	Eiji Kaida
Organization	Ainomemorial hospital
Division name	Department of orthopeadic surgery
Address	3838-1 Kou, Aino,Unzen city, Nagasaki prefecture, Japan
TEL	0957-36-0015
Email	ei2kaida@ainomhop.jp

Public contact
Name of contact person	Takayuki Nakamura
Organization	Ainomemorial hospital
Division name	Department of orthopeadic surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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