Case
(Ref.)

Age, sex

Antiretrovirals*

CD4, VL (cells/mL, (copies/mL)

Dx of AIDS

Duration of TDF mos.±

Clinical presentation

Site of fracture

Treatment

Outcome

1 [3]

45, F

DDI, LPV/RTV

187, <400

Yes

24

Shoulder, knee and rib pain, FS after osteomalacia

Pathologic pelvic and femoral neck

Calcium, Vitamin D

Serum creatinine normalized, FS resolved after 3 months

2 [4]

43, F

3TC, LPV/RTV

360, N/A

Yes

N/A

Foot, hip, knee pain , FS

Ankle and knee**, Pathologic femoral fracture

Potassium, Phosphate

Bone pain and FS improved

3 [12]

47, M

3TC, DDI, LPV/RTV

200, <200

Yes

16

Leg and heel pain, FS

Ribs**

Phosphate

Reduced bone pain, ALP resolved in 8 weeks; FS resolved over 8 months

4 [12]

56, F

ABC, LPV/RTV

210, 50

Yes

8

Knee and ankle pain, proximal myopathy, FS

N/A

Phosphate, Vitamin D

FS resolved after 2 weeks, myopathy; bone pains resolved over 3 months

5 [13]

N/A

N/A

N/A, <50

N/A

23

“osteomalacia”, FS

N/A

None

FS resolved in 3-4 months.  Per authors, “Osteomalacia” and elevated ALP not improved

6 [14]

51, F

RTV, 3TC, ATZ

290, <75

N/A

16

Leg and foot pain, FS

Legs, feet, pelvis, ribs**

Phosphate, Vitamin D

Pain improved in 2 weeks and resolved in 8 weeks, labs normalized in 12 weeks

7 (case 1)

46, F

ABC/AZT/3TC, LPV/RTV

981, <50

Yes

60

Foot, knee, chest wall pain, FS

Ribs, sacrum knees, feet, femur**

Phosphate

Pain improved in 21 days, and  resolved in 2 months, FS resolved

8 (case 2)

55, F

AZT/3TC,ATZ, Raltegravir LPV/RTV

341, <400

Yes

60

Ankle, shoulder, pain, L spine compression fracture, FS

Ribs, thoracic spine, sacrum**

Phosphate

Slow response after 1 month. Phosphorus and GFR improved, ALP remained high

9 (case 3)

60, M

LPV/RTV

366 <50

Yes

48

Foot, knee pain, FS

Knees, feet, femur**

Calcium, Phosphate, Calcitonin nasal spray

Pain resolved in 1 month., FS resolved, ALP decreased

Abbreviations: DDI=Didanosine; 3TC=Lamivudine; LPV/RTV=Lopinavir/Ritonavir; ABC=Abacavir; AZT=Zidovudine; ATZ=Atazanavir; FS=Fanconi Syndrome; ALP=Alkaline Phosphatase; GFR=Glomerular Filtration Rate; Dx=Diagnosis
Notes: * in addition to TDF, ±months prior to symptoms 1TDF stopped in all cases. Case 2, all HAART stopped. ** Stress fractures diagnosed by increased tracer activity on bone scan.
Table 1: Demographics and clinical outcomes in all 9 reported patients with TDF-associated osteomalacia.
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