Evaluation of fracture risk and potential drug holidays for postmenopausal women on long-term bisphosphonate therapy

Figures & data

Table 1 Fracture risk categorization criteria, treatment duration, and drug holiday duration

Risk category	Diagnosis	Number of risk factorsa	Treatment duration	Drug holiday
Low	Osteopeniab	0–2	Not indicated	n/a
Mild	Osteopeniab	>2	5 years	Until fracture or significant decrease in BMD
Moderate	Osteoporosisc	0–2	5–10 years	2–3 years
Highd	Osteoporosisc	>2	10 years	1–2 years

Notes:

a Age ≥70 years old; corticosteroid use of ≥5 mg prednisone or equivalent for ≥3 months ever; ≥3 alcohol drinks/day; low BMI (defined as <18 kg/m²); parental history of hip fracture; white or Asian race; secondary osteoporosis, rheumatoid arthritis;¹²

b defined as most recent T-score between −1 and −2.5;

c defined as most recent T-score at or below −2.5;

d women with history of fragility fracture, categorized as high-risk.

Abbreviations: n/a, not applicable; BMD, bone mineral density; BMI, body mass index.

Table 2 Demographics

	Low-risk (n=74)	Mild-risk (n=10)	Moderate-risk (n=72)	High-risk (n=45)	Total (n=201)
Age
Mean ± SD, (range)	69.3±7.4 (57–89)	74.3±4.1 (70–82)	70.3±7.7 (56–88)	75.9±9.0 (55–89)	71.4±8.2 (55–89)
BMI
Mean ± SD, (range)	26.3±5.5 (17.8–42.0)	24.3±5.6 (16.1–34.3)	24.2±4.7 (17.1–39.3)	25.6±6.9 (14.3–46.8)	25.3±5.6 (14.3–46.8)
Treatment duration (months)
Mean ± SD, (range)*	70.2±11.7 (49–93)	69.6±14.3 (50–86)	69.4±11.5 (48–87)	72.0±12.6 (48–87)	70.3±11.9 (48–93)
Race, n (%)
Asian	6 (8.1)	0 (0)	13 (18.1)	2 (4.4)	21 (10.4)
Black	4 (5.4)	0 (0)	3 (4.2)	1 (2.2)	8 (4.0)
White	58 (78.4)	10 (100)	44 (61.1)	35 (77.8)	147 (73.1)
Other/unknown	6 (8.1)	0 (0)	12 (16.7)	7 (15.6)	25 (12.4)
Medications, n (%)
Alendronate	48 (64.9)	9 (90.0)	47 (65.3)	30 (66.7)	134 (66.7)
Ibandronate	3 (4.1)	0 (0)	0 (0)	3 (6.7)	6 (3.0)
Risedronate	5 (6.8)	1 (10.0)	12 (16.7)	6 (13.3)	24 (11.9)
Zoledronic acid	2 (2.7)	0 (0)	0 (0)	0 (0)	2 (1.0)
Two of the above	14 (18.9)	0 (0)	13 (18.1)	6 (13.3)	33 (16.4)
Three of the above	2 (2.7)	0 (0)	0 (0)	0 (0)	2 (1.0)

Note:

* The exact start date was unknown for 123/201 (61.2%) of women.

Abbreviations: SD, standard deviation; BMI, body mass index.

Figure 1 Primary outcome results: risk category (n, %).

Table 3 Drug holiday eligibility and estimated drug cost avoidance

	Low-risk (n=74)	Mild-risk (n=10)	Total (low and mild) (n=84)
Number of patients eligible (% of total population)	74 (36.8%)	7 (3.5%)	81 (40.3%)
Cumulative number of treatment months eligible for drug cost avoidance	5,198	123	5,321
Estimated drug cost avoidance	$45,482.50	$1,076.25	$46,558.75
Estimated drug cost avoidance/patient	$614.63	$153.75	$574.80

Table 4 Calcium and vitamin D documentation

Supplement documentation	Low-risk (n=74) n (%)	Mild-risk (n=10) n (%)	Moderate-risk (n=72) n (%)	High-risk (n=45) n (%)	Total (n=201) n (%)
Calcium only	2 (2.7)	2 (20.0)	3 (4.2)	3 (6.7)	10 (5.0)
Vitamin D only	13 (17.6)	1 (10.0)	10 (13.9)	6 (13.3)	30 (14.9)
Calcium and vitamin D	33 (44.6)	6 (60.0)	43 (59.7)	24 (53.3)	106 (52.7)
Neither	26 (35.1)	1 (10.0)	16 (22.2)	12 (26.7)	55 (27.4)

KanisJAWorld Health Organization Scientific GroupAssessment of Osteoporosis at the Primary Health-Care Level Technical report of the World Health Organization Collaborating Centre for Metabolic Bone DiseasesSheffield, UKUniversity of Sheffield2007

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