Assessing the Impact of Contraceptives on Bone Health Using 41Ca
Other Disorders of Bone Development and Growth
About this trial
This is an interventional basic science trial for Other Disorders of Bone Development and Growth focused on measuring Calcium Tracer, Oral Contraceptives, Contraceptive Vaginal Ring, Impact of contraceptives on bone health using 41Ca
Eligibility Criteria
Inclusion Criteria:
- Female
- Age 18-25 yrs
- BMI 18-29 kg/m2
- Non-smoking
- Willing to refrain from using hormonal contraceptives for the equilibration + baseline period of the study (~150 days)
- Availability to frequently visit the laboratory in the next 12 months
- Not currently pregnant nor intending to become pregnant in the next 12 months
- Not lactating
- No apparent metabolic, endocrine, musculoskeletal, or severe psychiatric disease
- Willing to maintain consistent exercise (aerobic, weight-bearing) and dietary habits during pre-intervention and intervention periods
- Willing to refrain from supplements other than those provided by study staff in the next 12 months
- Variable physical activity acceptable, but mode must be primarily weight bearing
- At least 9 menses in the past 12 months
Exclusion Criteria:
- Non-weight bearing exercise as primary mode of physical activity
- Resistance exercise training (≥ 2 times 30 minutes per week of resistance exercise)
- Complete seasonal change of impact mode of physical activity
- Known or suspected metabolic or endocrine disease
- Smoking
- Pregnant
- Currently consuming large amounts of soy products
- Current clinical eating disorder or other axis 1 psychiatric disorder or bipolar disorders
- Oral or hormonal contraceptive use in the last 6 months
- Hyperparathyroidism
- Liver or renal disease
- Evidence of malabsorption or skeletal disorder
- Thyroid abnormalities (controlled hypothyroidism acceptable)
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDS)
- Taking medications known to have interactions with oral or vaginal contraceptive therapy
- Other Exclusion Criteria proposed by the World Health Organization COC Contraindications (Grossman et al., 2011).
Sites / Locations
- Women's Health and Exercise Laboratories, The Pennsylvania State University
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Combined Oral Contraceptive (COC)
Contraceptive Vaginal Ring (CVR)
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.
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.