Condition category
Musculoskeletal Diseases
Date applied
22/08/2012
Date assigned
31/08/2012
Last edited
31/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christopher Haines

ORCID ID

Contact details

The Chinese University of Hong Kong
Prince of Wales Hospital
Shatin
-
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CRE-2009.385-T

Study information

Scientific title

A pilot study to compare the effect of oestrogen combined with a progestogen in the form of either an oral contraceptive (OC) or hormone replacement therapy (HRT) on bone mineral density (BMD) in normogonadotropic hypoestrogenic anovulatory women.

Acronym

Study hypothesis

That oral contraceptives and hormone replacement therapy are equally effective in preventing osteoporosis in normogonadotropic anovulatory women.

Ethics approval

Clinical Research Ethics Committee of the Chinese University of Hong Kong, 23 August 2009, ref: CRE-2009.385-T

Study design

Prospective randomised control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prevention of osteoporosis

Intervention

Randomization to treatment with either:
Microgynon 30 ED OC (ethinylestradiol 0.03mg, levonorgestrel 0.15 mg daily for 21 days with 7 days lactose tablet)
OR
Femoston (oestradiol 2mg daily for 14 days, oestradiol 2 mg daily plus dydrogesterone 10mg daily for 14 days)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in BMD in either spine or femoral neck using dual-energy x-ray absorptiometry (DEXA)

Secondary outcome measures

Change in serum bone markers
1. Estimate of bone formation by measurement of serum bone-specific alkaline phosphatase (sBSAP)
2. Estimate of bone resorption by measurement of serum degradation products of C-terminal telopeptides of type 1 collagen (sCTX)
3. Changes of well-being as measured by Women's Health Questionnaire (WHQ)

Overall trial start date

16/09/2009

Overall trial end date

30/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged 20-45 years
2. Either 12 months of amenorrhoea or a menstrual cycle of average length 35 days or longer in the previous 12 months
3. At baseline Follicle-stimulating hormone (FSH) > 3.5 IU/L, < 10 IU/L
4. Luteinizing hormone (LH) > 2.4 IU/L, < 12.6 IU/L
5. E2 < 201 pmol/L
6. PRL < 496 mIU/L

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

1. On exogenous hormones within previous 3 months
2. Any contraindication to the use of female hormones
3. Any condition making it likely that they cannot complete the study
4. Hypergonadotropic or hypogonadotropic hypogonadism or hyperprolactinaemia as defined by abnormal FSH, LH or Prolactin concentrations
5. Any personal or strong family history of breast cancer or endometrial cancer
6. History of pulmonary or venous thromboembolism

Recruitment start date

16/09/2009

Recruitment end date

30/09/2012

Locations

Countries of recruitment

Hong Kong

Trial participating centre

The Chinese University of Hong Kong
Shatin
-
Hong Kong

Sponsor information

Organisation

The Chinese University of Hong Kong (Hong Kong)

Sponsor details

Direct Grant for Research
Medicine Panel
Shatin
-
Hong Kong

Sponsor type

University/education

Website

http://www.cuhk.edu.hk/english/

Funders

Funder type

University/education

Funder name

The Chinese University of Hong Kong - Direct Grant for Research ref: 2041471 (Hong Kong)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes