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Low-dose combined oral contraceptives use is associated to lower bone mass in adolescents over a one-year period

Bone mineral density in adolescents using combined oral contraceptives

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5h9b3c
Enrollment
Unknown
Registered
2014-04-02
Start date
2010-03-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Mineral Density, Bone Mineral Content

Interventions

Experimental Group: 41 healthy adolescents using low dose contraceptives containing 20 µg ethinylestradiol and 150 µg desogestrel in a period of one year. Control Group: 26 healthy adolescents not us
Drug
D27.505.696.875.360

Sponsors

Faculdade de Medicina de Botucatu da Universidade Estadual Paulista "Julio de Mesquita Filho"
Lead Sponsor
Fundação de Amparo a Pesquisa do Estado de São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
12 Years to 19 Years

Inclusion criteria

Inclusion criteria: healthy female volunteers; between 12 and 20 years old; who were post menarche and had regular menstrual cycles; attending the Adolescent Medicine Outpatient Clinic at Botucatu University Hospital from the São Paulo State University -UNESP; not using any type of hormonal contraceptive.

Exclusion criteria

Exclusion criteria: premature or low birth weight; prolonged steroid treatment; with diabetes mellitus, acute or chronic malnutrition, congenital or acquired bone diseases, gastrointestinal malabsorption, history of nephropathy, endocrinopathies; early or late puberty; chronic drug consumption; use of medication known to negatively affect bone metabolism.

Design outcomes

Primary

MeasureTime frame
To compare the Bone Mineral Density evaluated with dual-energy X-ray absorptiometry (DXA) using a Hologic QDR 4500 Discovery A apparatus of adolescents using low dose contraceptives with results from healthy adolescents not using contraceptives.;Contraceptives users presented low bone mass acquisition in the lumbar spine bone mineral density with variation percentages between initial and final moments (+2.07%). The control group presented variations (+12.16%) over the same period.—

Secondary

MeasureTime frame
The use of a low COC dose with Ethinylestradiol 20µg/Desogestrel 150µg was associated to lower bone mass acquisition in adolescents during the study period.—

Countries

Brazil

Contacts

Public ContactTalita Biason

Faculdade de Medicina de Botucatu da Universidade Estadual Paulista "Julio de Mesquita Filho"

talitapoli@uol.com.br+55-14-3811 6274

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 17, 2026