UMIN-CTR Clinical Trial

Public title

Effects of long-acting alendronate on osteoporosis with impaired glucose metabolism

Acronym

Fushimi Bone Study

Scientific Title

Effects of long-acting alendronate on osteoporosis with impaired glucose metabolism

Scientific Title:Acronym

Fushimi Bone Study

Region

Japan

Condition

Osteoporosis

Classification by specialty

Medicine in general

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of the study is to elucidate the effects of long-acting alendronate on the osteoporosis with and without impaired glucose metabolism

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

The first outcome is the effects of long-acting alendronate on the osteoporosis and the second outcome is the comparison of the effects between the patients with and without impaired glucose metabolism

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

50

years-old

<=

Age-upper limit

85

years-old

>=

Gender

Male and Female

Key inclusion criteria

Outpatients fullfilling the following 1) or 2) and 3) criteria
1)patients in which bone mineral density or femoral neck bone determined by DXA method is less than 70% of the young adult mean (YAM)

2)patients in which bone mineral density or femoral neck bone by DXA method is between 70% and 80%
(1) postmenopausal female
or (2) male patients with at least one of the following risks: excess alcohol drinking (more than 2 units/day), present smoking habit, or family history of femoral neck bone fracture

3)aged between 50 years and 85 years

Key exclusion criteria

1) patient taking bisphosphonates
2) patients contraindicated for alendronate
3) patients under treatment of glucocorticoid or with a history of treatment for 3 years or more.
4) disease states causing secondary osteoporosis: primary hyperparathyroidism, hyperthyroidism, hypogonadism, chronic rheumatic arthritis, multiple myeloma and other hematological diseases,Cushing's syndrome, immobilization, mesotholexate
5) type I diabetes mellitus, diabetes associated with other specific diseases and pregnancy
6) patients not suitable for measuring bone mineral density due to the history of supine bone fracture
7) other various conditions in which the attending doctor decide not suitable for entry.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Mitsuhide Naruse

Organization

National Hospital Organization, Kyoto Medical Center

Division name

Department Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases

Zip code

Address

1-1 Fukakusa, Mukaihata-cho, Fushimi-ku, Kyoto, Japan

TEL

075-641-9161

Email

Name of contact person

1st name
Middle name
Last name	Mitsuhide Naruse

Organization

National Hospital Organization, Kyoto Medical Center

Division name

Department Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases

Zip code

Address

1-1 Fukakusa, Mukaihata-cho, Fushimi-ku, Kyoto, Japan

TEL

075-641-9161

Homepage URL

Email

mnaruse@kyotolan.hosp.go.jp

Institute

National Hospital Organization, Kyoto Medical Center

Institute

Department

Personal name

Organization

National Hospital Organization,Kyoto Medical Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

National Hospital Organization, Saitama Hospital
Tsuji Clinic
Oishi Clinic
Ogawa Clinic
Kitani Clinic
Taniguchi Clinic
Tsukuda Clinic
Higashimae Clinic
Furukawa Clinic
Furuke Clinic
Wakabayashi Clinic

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2007

Year

06

Month

19

Day

Date of IRB

Anticipated trial start date

2007

Year

07

Month

01

Day

Last follow-up date

2010

Year

09

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Type 2 diabetes mellitus is a secondary cause of osteoporosis with high risk for bone fracture and deteriorated QOL. The aim of the study is to investigate the effects of long-acting alendronate on the osteoporosis and to compare the effects between the patients with and without impaired glucose metabolism. Outpatients aged between 50 and 85 years, fullfilling the criteria of the osteoporosis, were enrolled to the study after obtaining written informed consent. Before and after treatment with long-acting alendronate for 6 months, blood and urine tests and determination of BMD were investigated.

Registered date

2008

Year

01

Month

21

Day

Last modified on

2016

Year

03

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001189