Contraceptives for Bone Health
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different contraceptives affect bone health in young, active women. Researchers compare the effects of oral contraceptive pills (Combined Oral Contraceptives, or COCs) and a contraceptive vaginal ring (CVR) on bone calcium balance. The study may suit women aged 18-25 who exercise regularly and are not currently using hormonal contraceptives, pregnant, or smoking. Participants must maintain their usual exercise and diet habits and visit the lab frequently over the next year. As a Phase 4 trial, the contraceptives are already FDA-approved and proven effective, and this research aims to understand how they benefit more patients.
Will I have to stop taking my current medications?
The trial requires participants to stop using hormonal contraceptives for about 150 days before the study starts. Additionally, you must refrain from taking supplements not provided by the study staff and avoid medications that interact with contraceptive therapy.
What is the safety track record for these treatments?
Research shows that both the combined oral contraceptive (COC) pill and the contraceptive vaginal ring (CVR) are generally safe, though they may have different side effects and impacts on bone health.
Studies have found that COCs can affect bone strength, especially in young women. Some research suggests that COCs might slow bone growth in teenagers, a critical period for building strong bones. However, low-dose COCs are believed to be less harmful to bones than ultra-low-dose versions.
For the CVR, research indicates it is well tolerated by most users and usually doesn't cause many unwanted effects. While some people have experienced more side effects compared to other methods, it remains a generally safe option.
Both methods have been used in various forms and are approved for birth control, providing reassurance about their safety. However, discussing any concerns with a healthcare provider is important to choose the best option for individual needs.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the treatments in the "Contraceptives for Bone Health" trial because they examine how hormonal contraceptives might impact bone health differently than standard options. The Combined Oral Contraceptive (COC) uses a specific formulation of ethinyl estradiol (EE) and desogestrel that might influence bone density in a unique way. Meanwhile, the Contraceptive Vaginal Ring (CVR) delivers hormones via a ring inserted into the vagina, offering a different delivery method that might have distinct effects on bone health. These approaches could provide new insights into managing bone health for those using contraceptives, potentially offering benefits beyond traditional methods.
What evidence suggests that this trial's treatments could be effective for bone health?
Research has shown that combined oral contraceptives (COCs), one of the treatments tested in this trial, can benefit bone health. Studies have found that COCs can increase bone strength in the spine and help prevent bone loss in the hip. This likely occurs because COCs slow the weakening of bone tissue. Past use of oral contraceptives is also linked to stronger bones and a lower risk of osteoporosis, a condition where bones become weak and fragile.
In contrast, the contraceptive vaginal ring (CVR), another treatment option in this trial, does not appear to affect bone strength in healthy women before menopause. Studies found no significant change in bone strength after two years of using the vaginal ring. The method of contraceptive delivery—either as a pill or a ring—seems to affect bone health differently, with oral contraceptives showing more benefits for bone strength.26789Who Is on the Research Team?
Mary Jane De Souza, PhD
Principal Investigator
Penn State University
Are You a Good Fit for This Trial?
This trial is for young women aged 18-25 who are healthy, non-smokers, not currently pregnant or lactating, and have had a regular menstrual cycle. They should be willing to avoid hormonal contraceptives and supplements (except those provided by the study) for about 150 days before starting the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either oral contraceptive pills or a vaginal contraceptive ring for 49 days to assess the effects on bone turnover
Follow-up
Participants are monitored for changes in bone turnover markers and 41Ca:Ca ratio after the treatment phase
What Are the Treatments Tested in This Trial?
Interventions
- Combined Oral Contraceptive (COC)
- Contraceptive Vaginal Ring (CVR)
Trial Overview
The study is testing how two types of contraceptives—a pill (COC) and a vaginal ring (CVR)—affect bone health in active women. Using advanced technology, it will compare changes in bone calcium balance between these methods over time.
How Is the Trial Designed?
We are testing the effects of the vaginal ring (Nuva Ring; 15 µg/d EE, 120 µg/d etonogestrel). When randomized to CVR, participants will insert the contraceptive ring into their vagina . The ring will be worn during weeks 1-3, and again during weeks 5-7. During week 4, no ring will be worn to allow for withdrawal bleeding. If a participant is unable to collect a 24-h urine sample on day 49, they will insert a third ring which will remain in the vagina until she has collected a 24-h urine sample.
We are testing the effects of a COC (Apri (Reclipsen); 30 µg EE, 150 µg desogestrel). On the first day of the intervention, the participants randomized to COC will begin taking the pill. One pill will be ingested orally at the same time each day for days 1-49 of the intervention. Pills ingested during days 1-21 and during days 29-49 will be active tablets. Pills ingested on days 22-28 will be tablets without active ingredients. Each participant in the COC group will ingest a pill from the first pack each day for the first 28 days then begin the second pack. If a participant is unable to collect a 24-h urine sample on day 49, she will take active tablets from the third pill pack until she has collected the 24-h urine sample.
Combined Oral Contraceptive (COC) is already approved in United States, European Union, Canada for the following indications:
- Contraception
- Menstrual disorders
- Endometriosis
- Polycystic ovary syndrome (PCOS)
- Acne
- Hirsutism
- Contraception
- Menstrual disorders
- Endometriosis
- Polycystic ovary syndrome (PCOS)
- Acne
- Hirsutism
- Contraception
- Menstrual disorders
- Endometriosis
- Polycystic ovary syndrome (PCOS)
- Acne
- Hirsutism
Find a Clinic Near You
Who Is Running the Clinical Trial?
Penn State University
Lead Sponsor
Purdue University
Collaborator
Citations
EFFECT OF ORAL CONTRACEPTIVES ON BONE MINERAL ...
Combined Oral Contraceptives (COCs) may be detrimental to the BMD of adolescents. However, low-dose are more protective than ultra-low-dose COCs.
Effects of Combination Oral Contraceptives on Bone ...
We found that COCs increased BMD at LS and decreased bone loss at TH measured with DXA, probably by preventing decrease in cortical as well as trabecular bones.
Oral contraceptive use increases bone density and ...
We found prior OCP use to be associated with higher BMD and a reduced risk of osteoporosis, potentially offering long-term benefits.
Low-dose oral contraceptives and bone mineral density
After 2 years, the OC-treated subjects showed a significant decrease in urinary excretion of hydroxyproline and a significant increase in vertebral bone density ...
a systematic review with data from 5 million females
There is low certainty evidence that CHC use is associated with higher future fracture risk by up to 1.20 times, and total knee arthroplasty risk by up to 1.36 ...
“The pill” suppresses adolescent bone growth, no matter ...
CHC suppress bone resorption and therefore prevent the necessary bone growth that adolescents require to reach peak bone mineral density.
Appendix D: Classifications for Combined Hormonal ...
Effect of two kinds of different combined oral contraceptives use on bone mineral density in adolescent women. Contraception 2012;86:332–6 ...
Combined hormonal contraception and bone health
This systematic review examined whether women who use combined hormonal contraception experience changes in risk of fracture or bone mineral density (BMD) ...
9.
uptodate.com
uptodate.com/contents/combined-estrogen-progestin-oral-contraceptives-patient-selection-counseling-and-useCombined estrogen-progestin oral contraceptives
Longitudinal evaluation of perimenopausal bone loss: effects of different low dose oral contraceptive preparations on bone mineral density.
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