Gallagher JC, Rapuri PB, Haynatzki G, et al. Effect of discontinuation of estrogen, calcitriol, and the combination of both on bone density and bone markers. The Journal of Clinical Endocrinology & Metabolism 2002;87(11):4914-23
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/12414850
Full text article: https://academic.oup.com/jcem/article/87/11/4914/2823093
| Methods | Study design: Open-label randomized controlled trial with a parallel-design as a follow-on from a double-blind,randomized controlled trial
Number of groups: Four groups |
| Participants | Number of participants: 489 randomized, 178 completed
· Active deprescribing group (calcitriol): 123 randomized, 44 completed · Active deprescribing group (hormone replacement therapy (HRT)/estrogen replacement therapy (ERT)): 120 randomized: 38 completed · Active deprescribing group (calcitriol combined with HRT/ERT): 122 randomized, 40 completed · Control group: 123 randomized, 56 completed Age: 71.8 ± 0.31 years Sex: 489 female, 0 male Participants with dementia: No Inclusion criteria: · Female · Aged 65–77 years Exclusion criteria: · Severe chronic illness (chronic liver or kidney disease, severe COPD, severe rheumatoid arthritis, or serious heart failure) · Primary hyperparathyroidism · Active renal stone disease, · Taken certain medications, such as bisphosphonates, anticonvulsants, estrogen, fluoride, or thiazide diuretics, in the previous 6 months Country: United States of America Setting: Community |
| Interventions | Medicine:
· Calcitriol 0.25 mcg twice-daily, and/or · Conjugated equine estrogens [0.625 mg/daily; Premarin®; medroxyprogesterone acetate (2.5 mg/daily; Provera ®) was added if the woman had a uterus] Withdrawal schedule: Not described |
| Outcomes | · Mean Bone Mass Density for spine, total body, total femur, total hip, trochanter
· Urinary N- telopeptides · Serum osteocalcin · Serum parathyroid hormone · Serum 25OHOD levels |
| Dates | Dates: Not described
Follow-up duration: 5 years – 3 years treatment followed by 2 years deprescribing |
| Funding sources | NIH Research Grants UO1-AG-10373 and RO1-AG-10358 |
| Notes | There is no statement about conflict of interest.
*If this study is included in a meta-analysis, the placebo group and the deprescribing calcitriol group shall be used. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Unclear risk | Method not described
“subjects were assigned to four treatment groups using simple randomization stratified onhysterectomy status.” |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | High risk | The original study was double-blind, but the extension study does not appear to be blinded. |
| Blinding of outcome assessment (detection bias) | High risk | As above |
| Incomplete outcome data (attrition bias) | Low risk | The primary outcomes were as-treated, and for secondary outcomes there were a modified intention-to-treat analysis.
As-treated analysis – The analyzes were however performed only on the 178 women who came for the fifth year of the study |
| Selective reporting (reporting bias) | Low risk | The specified outcomes were reported. |
| Other bias | Unclear risk | It is unclear if this was pre-specified or an opportunistic study. |
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